Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults

• ClinicalTrials.gov Identifier: NCT03039790
• Recruitment Status: Completed
• First Posted: February 1, 2017
• Results First Posted: October 6, 2022
• Last Update Posted: November 9, 2022
• Sponsor: Takeda
• Information provided by (Responsible Party): Takeda

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Conditions: Healthy Volunteers; Norovirus
• Intervention: Biological: NoV Vaccine
• Enrollment: 528

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose	NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose	NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose	NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose	NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
Arm/Group Description	Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
Period Title: Overall Study
Started	25	19	27	27	23	27	25	28	22	28	21	25	24	24	24	29	39	14	35	42
Per Protocol Set (PPS) [1]	25	19	27	26	23	27	25	28	22	28	19	25	24	24	24	29	39	14	35	42
Completed	21	19	26	25	23	26	24	27	22	26	20	25	21	24	20	22	29	12	29	34
Not Completed	4	0	1	2	0	1	1	1	0	2	1	0	3	0	4	7	10	2	6	8
Reason Not Completed
Lost to Follow-up	2	0	1	1	0	1	1	1	0	1	1	0	1	0	3	1	2	2	1	3
Withdrawal of Consent	1	0	0	1	0	0	0	0	0	1	0	0	2	0	1	5	3	0	2	5
Death	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	3	0	2	0
Reason, not Specified	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	1	0
[1] PPS included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint.

Baseline Characteristics

Arm/Group Title		NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose	NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose	NOR-107: GI.1/GII.4 (15/150/167) μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose	NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose	NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose	NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose	Total
Arm/Group Description		Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Total of all reporting groups
Overall Number of Baseline Participants		25	19	27	27	23	27	25	28	22	28	21	25	24	24	24	29	39	14	35	42	528
Baseline Analysis Population Description		Full Analysis Set (FAS) included all participants with data from at least 1 follow-up time point.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	25 participants	19 participants	27 participants	27 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	21 participants	25 participants	24 participants	24 participants	24 participants	29 participants	39 participants	14 participants	35 participants	42 participants	528 participants
		48.1 (14.24)	47.9 (14.60)	46.8 (13.39)	47.5 (13.96)	48.0 (13.49)	48.0 (13.13)	45.4 (13.63)	46.8 (13.59)	45.5 (13.23)	44.0 (15.20)	41.9 (16.17)	42.6 (13.33)	47.3 (13.98)	46.3 (15.17)	35.0 (9.44)	73.6 (8.50)	77.2 (9.48)	35.6 (7.27)	76.9 (9.94)	76.1 (8.41)	53.6 (18.82)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	25 participants	19 participants	27 participants	27 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	21 participants	25 participants	24 participants	24 participants	24 participants	29 participants	39 participants	14 participants	35 participants	42 participants	528 participants
	Female	16 64.0%	13 68.4%	19 70.4%	20 74.1%	14 60.9%	21 77.8%	12 48.0%	14 50.0%	16 72.7%	21 75.0%	12 57.1%	15 60.0%	18 75.0%	16 66.7%	10 41.7%	20 69.0%	19 48.7%	7 50.0%	18 51.4%	23 54.8%	324 61.4%
	Male	9 36.0%	6 31.6%	8 29.6%	7 25.9%	9 39.1%	6 22.2%	13 52.0%	14 50.0%	6 27.3%	7 25.0%	9 42.9%	10 40.0%	6 25.0%	8 33.3%	14 58.3%	9 31.0%	20 51.3%	7 50.0%	17 48.6%	19 45.2%	204 38.6%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	25 participants	19 participants	27 participants	27 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	21 participants	25 participants	24 participants	24 participants	24 participants	29 participants	39 participants	14 participants	35 participants	42 participants	528 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	5 20.8%	1 3.4%	2 5.1%	1 7.1%	3 8.6%	3 7.1%	15 2.8%
	Not Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	19 79.2%	28 96.6%	37 94.9%	13 92.9%	32 91.4%	39 92.9%	168 31.8%
	Unknown or Not Reported	25 100.0%	19 100.0%	27 100.0%	27 100.0%	23 100.0%	27 100.0%	25 100.0%	28 100.0%	22 100.0%	28 100.0%	21 100.0%	25 100.0%	24 100.0%	24 100.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	345 65.3%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	25 participants	19 participants	27 participants	27 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	21 participants	25 participants	24 participants	24 participants	24 participants	29 participants	39 participants	14 participants	35 participants	42 participants	528 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%	1 3.7%	0 0.0%	1 3.7%	0 0.0%	0 0.0%	0 0.0%	1 3.6%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.6%	0 0.0%	0 0.0%	0 0.0%	4 0.8%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 7.1%	0 0.0%	0 0.0%	1 0.2%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	7 29.2%	1 3.4%	0 0.0%	1 7.1%	0 0.0%	3 7.1%	12 2.3%
	White	25 100.0%	19 100.0%	27 100.0%	26 96.3%	23 100.0%	26 96.3%	25 100.0%	28 100.0%	22 100.0%	27 96.4%	21 100.0%	25 100.0%	24 100.0%	24 100.0%	16 66.7%	28 96.6%	38 97.4%	12 85.7%	35 100.0%	39 92.9%	510 96.6%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 4.2%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 0.2%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	25 participants	19 participants	27 participants	27 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	21 participants	25 participants	24 participants	24 participants	24 participants	29 participants	39 participants	14 participants	35 participants	42 participants	528 participants
Belgium		25 100.0%	19 100.0%	27 100.0%	27 100.0%	23 100.0%	27 100.0%	25 100.0%	28 100.0%	22 100.0%	28 100.0%	21 100.0%	25 100.0%	24 100.0%	24 100.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	345 65.3%
United States		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	24 100.0%	29 100.0%	39 100.0%	14 100.0%	35 100.0%	42 100.0%	183 34.7%

Outcome Measures

1. Primary Outcome

Title	Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay
Description	GMBT50 of anti-norovirus GI. VLP antibody titers as measured by the histo-blood group antigen (HBGA) blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204) , at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107, NOR-210, NOR-204)
Time Frame	Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study

Outcome Measure Data

Analysis Population Description

Per Protocol Set (PPS) included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.

Arm/Group Title		NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose	NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose	NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose	NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose	NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
Arm/Group Description:		Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
Overall Number of Participants Analyzed		25	19	27	26	23	27	25	28	22	28	19	25	24	24	24	29	39	14	35	42
Geometric Mean (95% Confidence Interval); Unit of Measure: titer
Baseline	Number Analyzed	25 participants	19 participants	27 participants	26 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	19 participants	25 participants	24 participants	24 participants	24 participants	29 participants	39 participants	14 participants	35 participants	42 participants
		27.4; (17.5 to 42.9)	18.3; (13.4 to 24.9)	26.3; (17.4 to 39.6)	24.6; (15.5 to 38.9)	19.0; (15.5 to 23.2)	23.9; (17.2 to 33.2)	35.1; (21.7 to 56.9)	24.3; (16.5 to 35.8)	26.1; (16.8 to 40.5)	23.9; (17.5 to 32.7)	33.4; (19.4 to 57.6)	23.1; (16.4 to 32.6)	22.9; (15.9 to 32.9)	21.3; (15.4 to 29.3)	19.0; (14.1 to 25.6)	20.8; (16.4 to 26.3)	28.9; (20.7 to 40.5)	18.7; (13.0 to 26.9)	23.9; (18.5 to 30.8)	26.4; (19.4 to 36.1)
Days 28	Number Analyzed	25 participants	19 participants	26 participants	26 participants	23 participants	27 participants	25 participants	28 participants	21 participants	28 participants	19 participants	25 participants	24 participants	24 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
		27.7; (18.2 to 42.2)	18.1; (13.2 to 24.8)	23.8; (16.4 to 34.5)	24.0; (15.4 to 37.3)	17.4; (14.5 to 20.9)	21.9; (16.1 to 29.9)	29.9; (20.2 to 44.2)	24.9; (17.2 to 36.1)	27.3; (17.2 to 43.4)	25.8; (18.3 to 36.3)	34.9; (20.8 to 58.5)	382.6; (200.9 to 728.5)	338.0; (196.7 to 580.7)	449.4; (270.5 to 746.5)
Days 29	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	24 participants	29 participants	39 participants	14 participants	35 participants	42 participants
																212.5; (129.9 to 347.5)	21.3; (16.9 to 26.9)	28.7; (20.6 to 40.0)	19.9; (13.5 to 29.2)	342.5; (206.3 to 568.5)	329.2; (213.3 to 508.2)
Day 36	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	29 participants	39 participants	14 participants	35 participants	42 participants
																	263.3; (143.3 to 483.9)	213.4; (117.2 to 388.5)	155.3; (51.5 to 468.2)	406.4; (274.6 to 601.4)	307.2; (206.1 to 458.0)
Day 56	Number Analyzed	25 participants	19 participants	27 participants	26 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	19 participants	25 participants	24 participants	24 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
		309.7; (168.7 to 568.4)	256.9; (136.3 to 484.0)	380.9; (227.0 to 639.2)	255.4; (132.3 to 493.1)	252.9; (136.7 to 468.1)	329.2; (192.9 to 561.9)	369.5; (221.0 to 617.8)	350.4; (194.5 to 631.2)	527.0; (264.1 to 1051.5)	274.3; (171.6 to 438.4)	315.8; (154.5 to 645.2)	435.9; (288.8 to 658.0)	427.6; (300.0 to 609.6)	377.4; (251.6 to 566.0)
Day 57	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	29 participants	39 participants	14 participants	35 participants	42 participants
																	228.9; (136.4 to 384.1)	223.0; (133.9 to 371.5)	105.1; (40.9 to 270.5)	362.5; (255.9 to 513.5)	304.3; (215.6 to 429.7)
Day 208	Number Analyzed	25 participants	19 participants	27 participants	26 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	19 participants	25 participants	24 participants	24 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
		143.5; (84.7 to 243.2)	109.1; (62.9 to 189.1)	154.8; (95.7 to 250.4)	125.6; (74.9 to 210.8)	86.4; (50.5 to 148.1)	137.9; (93.7 to 202.8)	168.9; (109.1 to 261.5)	175.4; (111.6 to 275.6)	214.1; (120.7 to 379.6)	125.3; (83.7 to 187.6)	115.3; (61.5 to 216.0)	208.7; (134.0 to 324.9)	201.5; (141.3 to 287.4)	185.6; (126.9 to 271.6)
Day 211	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	29 participants	39 participants	14 participants	35 participants	42 participants
																	115.9; (72.1 to 186.4)	96.5; (62.6 to 148.7)	43.4; (20.1 to 93.9)	132.9; (89.2 to 198.0)	126.6; (85.6 to 187.2)
Year 2	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	24 participants	26 participants	37 participants	14 participants	32 participants	34 participants
																48.8; (31.2 to 76.4)	46.3; (30.7 to 69.8)	63.6; (39.6 to 102.1)	38.9; (16.7 to 90.6)	58.9; (39.8 to 87.2)	83.4; (58.2 to 119.3)
Year 3	Number Analyzed	24 participants	19 participants	27 participants	26 participants	23 participants	26 participants	25 participants	28 participants	22 participants	27 participants	19 participants	25 participants	24 participants	24 participants	21 participants	24 participants	35 participants	13 participants	29 participants	37 participants
		79.6; (48.9 to 129.7)	53.7; (32.8 to 88.0)	77.2; (49.1 to 121.3)	72.4; (44.0 to 119.1)	51.5; (33.1 to 80.1)	55.5; (35.4 to 86.8)	98.0; (65.1 to 147.5)	90.2; (60.1 to 135.5)	102.2; (56.4 to 185.0)	61.8; (40.5 to 94.3)	67.2; (34.5 to 131.1)	90.5; (55.4 to 147.6)	84.9; (53.1 to 135.6)	85.7; (55.9 to 131.4)	48.2; (29.0 to 80.1)	48.8; (30.3 to 78.8)	60.7; (37.2 to 98.9)	34.0; (16.6 to 69.9)	72.5; (47.3 to 111.2)	76.1; (51.0 to 113.6)
Year 4	Number Analyzed	23 participants	19 participants	26 participants	26 participants	23 participants	26 participants	23 participants	28 participants	22 participants	28 participants	19 participants	25 participants	23 participants	24 participants	20 participants	18 participants	22 participants	11 participants	20 participants	27 participants
		70.5; (38.0 to 130.9)	47.5; (27.3 to 82.7)	68.6; (38.6 to 122.0)	54.0; (30.4 to 96.1)	54.8; (30.2 to 99.7)	49.3; (31.5 to 77.2)	84.9; (49.6 to 145.2)	67.3; (41.1 to 109.9)	78.2; (41.9 to 146.1)	45.5; (30.0 to 68.9)	61.2; (30.9 to 121.0)	85.8; (57.9 to 127.0)	65.1; (39.0 to 108.8)	67.2; (42.9 to 105.2)	63.8; (35.0 to 116.2)	28.6; (17.3 to 47.2)	45.9; (25.0 to 84.3)	28.3; (14.2 to 56.2)	76.1; (45.6 to 127.2)	57.1; (34.5 to 94.3)
Year 5	Number Analyzed	21 participants	19 participants	26 participants	24 participants	23 participants	26 participants	24 participants	27 participants	22 participants	25 participants	19 participants	24 participants	21 participants	24 participants	19 participants	8 participants	13 participants	10 participants	10 participants	16 participants
		71.0; (37.8 to 133.6)	42.5; (25.0 to 72.4)	80.5; (45.0 to 144.0)	54.4; (30.8 to 96.2)	50.5; (28.7 to 89.1)	54.5; (31.0 to 96.0)	77.2; (48.4 to 123.1)	82.2; (49.0 to 137.7)	80.9; (43.3 to 151.1)	54.1; (32.6 to 89.7)	62.0; (32.5 to 118.5)	82.1; (50.9 to 132.4)	69.1; (42.3 to 112.6)	74.9; (49.1 to 114.2)	52.8; (28.6 to 97.4)	34.7; (15.8 to 76.1)	41.9; (21.8 to 80.3)	31.9; (14.6 to 69.6)	59.8; (29.0 to 123.2)	65.5; (37.9 to 113.1)

2. Primary Outcome

Title	Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay
Description	GMBT50 of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3 4 and 5 (NOR-107,NOR-210, NOR-204) .
Time Frame	Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study

Outcome Measure Data

Analysis Population Description

PPS included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.

Arm/Group Title		NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose	NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose	NOR-107: GI.1/GII.4 (15/15/167) μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg,2-Dose	NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose	NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose	NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
Arm/Group Description:		Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible participants who received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 in previous study NOR-210 were enrolled at 2nd year post-primary vaccination in this study.	Eligible participants ≥ 60 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	Eligible participants 60-94 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	Eligible participants 18 to 49 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Overall Number of Participants Analyzed		25	19	27	26	23	27	25	28	22	28	19	25	24	24	24	29	39	14	35	42
Geometric Mean (95% Confidence Interval); Unit of Measure: titer
Baseline	Number Analyzed	25 participants	19 participants	27 participants	26 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	19 participants	25 participants	24 participants	24 participants	24 participants	29 participants	39 participants	14 participants	35 participants	42 participants
		74.8; (38.1 to 147.0)	77.4; (41.9 to 142.8)	116.8; (65.9 to 207.2)	72.1; (41.6 to 125.1)	54.6; (30.7 to 97.3)	104.2; (60.4 to 179.8)	77.5; (42.5 to 141.6)	86.3; (47.9 to 155.3)	97.1; (55.8 to 169.0)	106.1; (66.7 to 168.8)	124.3; (69.0 to 223.9)	65.8; (39.6 to 109.1)	97.2; (53.8 to 175.9)	127.3; (70.2 to 231.0)	42.7; (25.6 to 71.1)	140.5; (78.5 to 251.6)	71.8; (45.7 to 113.0)	97.5; (40.3 to 235.8)	104.9; (64.2 to 171.5)	111.0; (72.0 to 171.1)
Day 28	Number Analyzed	25 participants	19 participants	26 participants	26 participants	23 participants	27 participants	25 participants	28 participants	21 participants	28 participants	19 participants	25 participants	24 participants	24 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
		80.7; (42.3 to 153.9)	67.2; (35.2 to 128.0)	128.0; (73.3 to 223.7)	71.3; (42.2 to 120.7)	64.9; (36.6 to 115.3)	101.3; (57.1 to 179.6)	69.7; (40.2 to 120.9)	95.2; (49.6 to 182.6)	84.1; (46.7 to 151.3)	129.9; (83.4 to 202.4)	112.4; (63.0 to 200.5)	607.7; (379.2 to 974.0)	668.3; (397.3 to 1124.0)	893.6; (578.4 to 1380.5)
Day 29	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	24 participants	29 participants	39 participants	14 participants	35 participants	42 participants
																665.9; (408.2 to 1086.2)	118.3; (66.7 to 210.0)	63.5; (41.0 to 98.4)	83.2; (34.3 to 201.9)	1134.4; (784.6 to 1640.1)	824.2; (493.4 to 1376.8)
Day 36	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	29 participants	39 participants	14 participants	35 participants	42 participants
																	920.9; (521.8 to 1625.4)	518.7; (273.0 to 985.2)	1037.4; (448.1 to 2401.9)	1016.2; (719.4 to 1435.4)	766.8; (483.1 to 1216.9)
Day 56	Number Analyzed	25 participants	19 participants	27 participants	26 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	19 participants	25 participants	24 participants	24 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
		367.9; (214.8 to 630.3)	755.9; (425.6 to 1342.6)	425.1; (298.8 to 604.8)	277.9; (178.2 to 433.4)	584.7; (367.5 to 930.1)	593.4; (436.2 to 807.2)	201.9; (110.6 to 368.4)	810.0; (507.4 to 1293.2)	328.5; (173.8 to 620.8)	886.3; (562.3 to 1397.0)	746.6; (456.8 to 1220.3)	458.4; (290.9 to 722.3)	575.5; (358.1 to 924.8)	594.2; (369.2 to 956.2)
Day 57	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	29 participants	39 participants	14 participants	35 participants	42 participants
																	1133.2; (682.7 to 1881.0)	471.8; (285.2 to 780.5)	663.8; (304.5 to 1447.1)	740.2; (549.0 to 998.0)	589.1; (359.7 to 964.6)
Day 208	Number Analyzed	25 participants	19 participants	27 participants	26 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	19 participants	25 participants	24 participants	24 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
		216.4; (132.8 to 352.6)	290.1; (182.7 to 460.7)	231.4; (152.0 to 352.4)	176.2; (116.1 to 267.4)	215.9; (132.1 to 353.1)	247.4; (166.6 to 367.3)	150.4; (87.4 to 258.6)	333.2; (217.9 to 509.4)	173.0; (94.8 to 315.8)	352.9; (242.4 to 513.8)	274.9; (151.4 to 499.2)	277.2; (186.5 to 412.0)	342.5; (233.2 to 503.1)	308.7; (198.5 to 480.0)
Day 211	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	29 participants	39 participants	14 participants	35 participants	42 participants
																	417.6; (252.8 to 689.6)	195.2; (120.2 to 316.8)	274.7; (135.3 to 557.8)	374.7; (262.6 to 534.6)	265.3; (157.4 to 447.2)
Year 2	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	24 participants	26 participants	37 participants	10 participants	32 participants	35 participants
																105.2; (58.7 to 188.3)	223.2; (120.7 to 412.9)	122.5; (74.8 to 200.5)	250.5; (80.8 to 776.7)	220.9; (137.2 to 355.7)	243.0; (149.6 to 394.7)
Year 3	Number Analyzed	24 participants	19 participants	27 participants	26 participants	23 participants	27 participants	25 participants	28 participants	22 participants	27 participants	19 participants	25 participants	24 participants	24 participants	21 participants	24 participants	35 participants	13 participants	29 participants	37 participants
		122.7; (65.7 to 229.2)	177.1; (96.8 to 323.9)	117.9; (69.6 to 199.7)	104.0; (60.2 to 179.6)	80.5; (45.4 to 142.9)	125.9; (74.7 to 212.3)	121.2; (71.1 to 206.7)	164.1; (97.7 to 275.5)	125.3; (67.9 to 230.9)	167.0; (111.3 to 250.4)	142.2; (76.9 to 263.1)	149.2; (83.1 to 267.9)	144.7; (83.1 to 251.7)	173.8; (104.6 to 288.8)	87.5; (43.9 to 174.5)	172.0; (100.1 to 295.5)	94.9; (59.4 to 151.3)	133.8; (56.2 to 318.9)	153.3; (100.1 to 234.8)	162.4; (102.5 to 257.3)
Year 4	Number Analyzed	23 participants	19 participants	26 participants	26 participants	23 participants	26 participants	23 participants	28 participants	22 participants	28 participants	19 participants	25 participants	23 participants	24 participants	20 participants	18 participants	22 participants	11 participants	20 participants	27 participants
		85.7; (46.7 to 157.1)	122.8; (67.4 to 223.6)	90.8; (54.4 to 151.3)	79.5; (48.3 to 130.8)	61.7; (35.7 to 106.5)	106.7; (64.7 to 176.1)	108.6; (62.0 to 190.3)	131.2; (81.9 to 210.2)	101.9; (60.1 to 172.7)	113.9; (73.3 to 177.1)	130.1; (70.0 to 241.9)	98.1; (55.0 to 175.1)	104.4; (58.4 to 186.5)	120.3; (72.6 to 199.3)	84.1; (44.2 to 160.3)	116.0; (54.0 to 249.4)	80.9; (42.1 to 155.4)	131.1; (57.6 to 298.6)	241.9; (140.2 to 417.5)	136.7; (75.7 to 246.9)
Year 5	Number Analyzed	21 participants	19 participants	26 participants	24 participants	23 participants	26 participants	24 participants	27 participants	22 participants	25 participants	19 participants	24 participants	21 participants	24 participants	19 participants	8 participants	14 participants	10 participants	10 participants	17 participants
		101.1; (52.5 to 194.6)	138.3; (80.8 to 236.9)	124.4; (78.5 to 197.0)	91.2; (51.2 to 162.3)	71.3; (40.0 to 126.9)	103.2; (60.6 to 175.8)	94.3; (54.4 to 163.2)	144.9; (82.9 to 253.1)	105.1; (57.8 to 191.1)	147.2; (92.4 to 234.4)	118.0; (66.8 to 208.6)	118.3; (71.4 to 195.8)	115.7; (57.7 to 232.0)	132.0; (79.7 to 218.5)	94.2; (49.1 to 180.7)	123.4; (26.5 to 574.3)	66.8; (32.2 to 138.6)	107.4; (43.5 to 265.1)	202.2; (110.2 to 370.9)	187.3; (105.6 to 332.4)

3. Secondary Outcome

Title	Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)
Description	GMT of anti-norovirus GI.1 VLP antibody titers as measured by total immunoglobulin (pan-Ig) enzyme-linked immunoassay (ELISA). Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5(NOR-107,NOR-210, NOR-204).
Time Frame	Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study

Outcome Measure Data

Analysis Population Description

PPS included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.

Arm/Group Title		NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose	NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose	NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose	NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose	NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
Arm/Group Description:		Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 in previous study NOR-210 were enrolled at 2nd year post-primary vaccination in this study.	Eligible participants ≥ 60 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	Eligible participants 60-94 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	Eligible participants 18 to 49 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Overall Number of Participants Analyzed		25	19	27	26	23	27	25	28	22	28	19	25	24	24	24	29	39	14	35	42
Geometric Mean (95% Confidence Interval); Unit of Measure: titer
Baseline	Number Analyzed	25 participants	19 participants	27 participants	26 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	19 participants	25 participants	24 participants	24 participants	24 participants	29 participants	39 participants	14 participants	35 participants	42 participants
		1030.5; (543.6 to 1953.7)	689.8; (295.3 to 1611.4)	646.2; (354.3 to 1178.4)	620.9; (326.7 to 1180.1)	547.4; (334.5 to 895.6)	539.6; (293.3 to 992.5)	1089.2; (599.9 to 1977.6)	856.1; (471.5 to 1554.3)	749.7; (406.6 to 1382.5)	770.6; (413.5 to 1436.2)	925.3; (366.0 to 2339.3)	777.3; (413.1 to 1462.8)	908.6; (501.0 to 1647.8)	640.4; (378.5 to 1083.5)	160.1; (78.6 to 326.1)	671.5; (432.5 to 1042.4)	769.8; (559.5 to 1059.0)	493.1; (170.7 to 1424.8)	683.8; (460.7 to 1014.9)	851.8; (534.3 to 1357.9)
Day 28	Number Analyzed	25 participants	19 participants	26 participants	26 participants	23 participants	27 participants	25 participants	28 participants	21 participants	28 participants	19 participants	25 participants	24 participants	24 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
		975.2; (508.7 to 1869.6)	649.3; (285.2 to 1478.2)	544.9; (297.5 to 998.3)	648.7; (324.3 to 1297.5)	475.4; (284.8 to 793.4)	535.4; (287.5 to 997.1)	1086.1; (613.7 to 1922.0)	839.1; (469.7 to 1499.0)	729.3; (380.1 to 1399.5)	731.0; (382.7 to 1396.2)	932.8; (402.0 to 2164.8)	16822.8; (11052.9 to 25604.9)	21215.2; (15921.0 to 28269.9)	14102.7; (9666.5 to 20574.8)
Day 29	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	24 participants	29 participants	39 participants	14 participants	35 participants	42 participants
																10798.6; (7482.3 to 15584.8)	630.6; (407.9 to 974.8)	734.8; (544.2 to 992.1)	694.7; (249.8 to 1931.4)	10862.2; (8363.3 to 14107.7)	8286.7; (6204.3 to 11068.0)
Day 36	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	29 participants	39 participants	14 participants	35 participants	42 participants
																	6915.9; (4770.3 to 10026.5)	3909.4; (2555.3 to 5981.0)	7407.6; (3545.0 to 15479.0)	10851.2; (8549.3 to 13772.9)	8143.0; (6132.6 to 10812.4)
Day 56	Number Analyzed	25 participants	19 participants	27 participants	26 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	19 participants	25 participants	24 participants	24 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
		15032.5; (10033.4 to 22522.2)	12246.2; (7488.7 to 20025.9)	16739.1; (11460.0 to 24450.0)	13673.2; (8411.3 to 22226.9)	12847.2; (9036.9 to 18264.2)	18464.0; (14207.7 to 23995.3)	15242.3; (11298.2 to 20563.2)	15071.0; (9104.8 to 24946.5)	25738.6; (16696.8 to 39676.9)	14709.3; (10110.9 to 21399.2)	12428.4; (6942.7 to 22248.5)	14302.9; (10081.6 to 20291.8)	18086.8; (13594.7 to 24063.2)	11282.4; (8142.8 to 15632.5)
Day 57	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	29 participants	39 participants	14 participants	35 participants	42 participants
																	10684.3; (8532.4 to 13378.9)	5646.8; (4043.4 to 7886.1)	7944.8; (4570.2 to 13811.2)	9388.2; (7285.3 to 12098.2)	7316.3; (5685.6 to 9414.7)
Day 208	Number Analyzed	25 participants	19 participants	27 participants	26 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	19 participants	25 participants	24 participants	24 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
		6015.9; (4271.9 to 8471.9)	4784.5; (3114.9 to 7349.0)	6231.0; (4321.0 to 8985.3)	5675.5; (3783.7 to 8513.4)	4212.3; (3065.0 to 5789.1)	4997.4; (3748.7 to 6662.0)	5577.8; (4072.7 to 7639.2)	6686.7; (4766.4 to 9380.5)	7761.2; (5226.5 to 11525.1)	5274.3; (3746.7 to 7424.6)	4978.7; (3275.4 to 7567.6)	7082.7; (5051.7 to 9930.2)	7469.9; (5874.5 to 9498.6)	5355.9; (4082.7 to 7026.2)
Day 211	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	29 participants	39 participants	14 participants	35 participants	42 participants
																	5970.0; (4586.1 to 7771.7)	4137.3; (3176.2 to 5389.2)	3745.8; (1975.8 to 7101.5)	5320.5; (4169.4 to 6789.4)	5020.4; (3878.5 to 6498.6)
Year 2	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	24 participants	26 participants	37 participants	10 participants	32 participants	35 participants
																1662.0; (1203.1 to 2296.0)	1804.4; (1405.6 to 2316.4)	1477.4; (1016.3 to 2147.7)	1672.4; (656.0 to 4263.7)	1770.6; (1310.4 to 2392.3)	1635.0; (1194.2 to 2238.4)
Year 3	Number Analyzed	24 participants	19 participants	27 participants	26 participants	23 participants	27 participants	25 participants	28 participants	22 participants	27 participants	19 participants	25 participants	24 participants	24 participants	21 participants	24 participants	35 participants	13 participants	29 participants	37 participants
		2229.0; (1481.3 to 3354.1)	1493.3; (987.8 to 2257.6)	2058.7; (1538.0 to 2755.7)	2227.0; (1581.4 to 3136.2)	1465.7; (1056.7 to 2032.8)	1568.0; (1188.6 to 2068.5)	2156.1; (1527.7 to 3042.9)	1913.2; (1386.8 to 2639.4)	2063.1; (1370.8 to 3105.0)	1702.4; (1165.5 to 2486.6)	1579.5; (977.5 to 2552.2)	2422.7; (1732.0 to 3388.9)	2914.8; (2270.4 to 3742.1)	2077.8; (1523.3 to 2834.1)	1500.9; (1031.3 to 2184.2)	2006.4; (1373.3 to 2931.3)	1932.8; (1245.7 to 2998.7)	1254.9; (701.7 to 2244.2)	1670.1; (1258.5 to 2216.4)	1700.5; (1224.7 to 2361.3)
Year 4	Number Analyzed	23 participants	19 participants	26 participants	26 participants	23 participants	26 participants	23 participants	28 participants	22 participants	28 participants	19 participants	25 participants	23 participants	24 participants	20 participants	18 participants	22 participants	11 participants	20 participants	27 participants
		2095.5; (1272.0 to 3452.2)	1727.7; (1016.1 to 2937.8)	2541.1; (1618.3 to 3990.1)	1958.2; (1363.0 to 2813.3)	1802.9; (1185.9 to 2740.8)	1565.5; (1181.0 to 2075.1)	2934.1; (1993.0 to 4319.7)	2107.0; (1384.3 to 3207.0)	1965.0; (1287.9 to 2997.9)	1679.0; (1208.0 to 2333.5)	2025.2; (1254.9 to 3268.3)	2335.8; (1724.4 to 3163.8)	2635.7; (1936.2 to 3587.9)	2016.6; (1500.0 to 2711.1)	1627.4; (1127.0 to 2350.1)	1512.1; (1032.5 to 2214.6)	1441.7; (926.9 to 2242.4)	1238.3; (841.5 to 1822.1)	1585.6; (1101.6 to 2282.3)	1392.4; (917.6 to 2112.9)
Year 5	Number Analyzed	21 participants	19 participants	26 participants	24 participants	23 participants	26 participants	24 participants	27 participants	22 participants	25 participants	19 participants	24 participants	21 participants	24 participants	19 participants	8 participants	15 participants	10 participants	10 participants	16 participants
		1732.3; (1133.8 to 2646.8)	1563.6; (957.9 to 2552.6)	2345.8; (1566.6 to 3512.7)	2009.8; (1396.6 to 2892.2)	1664.8; (1100.7 to 2518.1)	1781.2; (1102.5 to 2877.7)	2116.5; (1597.7 to 2803.7)	2270.3; (1536.1 to 3355.5)	2181.9; (1360.4 to 3499.2)	1811.9; (1173.5 to 2797.8)	1434.9; (956.9 to 2151.6)	2036.9; (1475.0 to 2812.9)	2405.4; (1763.1 to 3281.8)	1817.7; (1256.1 to 2630.5)	1803.8; (1205.4 to 2699.1)	1937.4; (1141.5 to 3288.2)	1255.5; (709.1 to 2223.1)	1048.6; (566.7 to 1940.4)	2060.5; (1422.7 to 2984.3)	1687.2; (1031.7 to 2759.3)

4. Secondary Outcome

Title	Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA
Description	GMT of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. Data reported for up to Year 5 was collected at Baseline (NOR-107,NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107,NOR-210, NOR-204).
Time Frame	Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study

Outcome Measure Data

Analysis Population Description

PPS included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.

Arm/Group Title		NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose	NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose	NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose	NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose	NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose	NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose	NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose	NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
Arm/Group Description:		Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	Eligible participants who received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 in previous study NOR-210 were enrolled at 2nd year post-primary vaccination in this study.	Eligible participants ≥ 60 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	Eligible participants 60-94 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	Eligible participants 18 to 49 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Overall Number of Participants Analyzed		25	19	27	26	23	27	25	28	22	28	19	25	24	24	24	29	39	14	35	42
Geometric Mean (95% Confidence Interval); Unit of Measure: titer
Baseline	Number Analyzed	25 participants	19 participants	27 participants	26 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	19 participants	25 participants	24 participants	24 participants	24 participants	29 participants	39 participants	14 participants	35 participants	42 participants
		1209.8; (617.2 to 2371.5)	1248.3; (665.1 to 2343.0)	1423.3; (799.5 to 2533.7)	954.0; (530.1 to 1716.8)	838.8; (507.6 to 1386.1)	1239.7; (705.8 to 2177.4)	1373.7; (792.4 to 2381.6)	1179.5; (677.5 to 2053.4)	1133.9; (648.4 to 1982.8)	1442.1; (864.3 to 2406.1)	2069.2; (1362.0 to 3143.7)	1078.9; (678.4 to 1715.6)	1308.9; (779.3 to 2198.4)	1598.5; (952.6 to 2682.3)	93.1; (58.8 to 147.3)	1213.2; (658.2 to 2236.1)	826.1; (508.7 to 1341.7)	1288.0; (570.8 to 2906.4)	1263.5; (794.7 to 2009.0)	1149.0; (672.9 to 1961.8)
Day 28	Number Analyzed	25 participants	19 participants	26 participants	26 participants	23 participants	27 participants	25 participants	28 participants	21 participants	28 participants	19 participants	25 participants	24 participants	24 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
		1218.3; (609.8 to 2433.7)	1233.2; (658.4 to 2309.7)	1471.1; (841.2 to 2572.7)	953.8; (549.5 to 1655.4)	754.4; (464.2 to 1226.0)	1198.8; (688.3 to 2088.0)	1310.7; (797.3 to 2154.5)	1246.3; (710.3 to 2187.0)	1086.0; (619.5 to 1903.7)	1491.7; (983.7 to 2262.0)	1940.6; (1259.0 to 2991.2)	8866.0; (6415.5 to 12252.6)	13710.2; (10111.0 to 18590.5)	10202.3; (6715.1 to 15500.5)
Day 29	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	24 participants	29 participants	39 participants	14 participants	35 participants	42 participants
																10170.0; (7301.6 to 14165.2)	1172.6; (630.4 to 2181.1)	818.6; (510.4 to 1313.0)	1251.3; (563.1 to 2780.5)	9284.7; (6772.0 to 12729.9)	8508.2; (5798.6 to 12484.1)
Day 36	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	29 participants	39 participants	14 participants	35 participants	42 participants
																	5938.0; (3771.8 to 9348.2)	4248.1; (2787.2 to 6474.8)	8348.3; (5370.9 to 12976.3)	9415.5; (7120.6 to 12450.1)	8518.7; (5970.1 to 12155.2)
Day 56	Number Analyzed	25 participants	19 participants	27 participants	26 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	19 participants	25 participants	24 participants	24 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
		5051.3; (3144.0 to 8115.7)	8644.5; (6368.1 to 11734.7)	5651.7; (4159.3 to 7679.4)	3909.2; (2620.5 to 5831.7)	6655.7; (4670.1 to 9485.5)	7585.7; (5687.6 to 10117.3)	3296.3; (2075.7 to 5234.7)	9110.9; (5865.5 to 14152.2)	4762.7; (2918.8 to 7771.4)	10733.0; (7902.0 to 14578.1)	9544.8; (6846.7 to 13306.1)	7083.6; (5125.3 to 9790.1)	10333.3; (7485.5 to 14264.4)	7801.7; (5379.1 to 11315.4)
Day 57	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	29 participants	39 participants	14 participants	35 participants	42 participants
																	9761.9; (6487.9 to 14688.1)	5961.1; (4365.7 to 8139.7)	8689.8; (6309.5 to 11968.1)	7673.7; (5733.9 to 10269.7)	7610.5; (5336.3 to 10854.0)
Day 208	Number Analyzed	25 participants	19 participants	27 participants	26 participants	23 participants	27 participants	25 participants	28 participants	22 participants	28 participants	19 participants	25 participants	24 participants	24 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
		2805.0; (1665.3 to 4724.8)	3797.7; (2654.3 to 5433.8)	2757.9; (1631.0 to 4663.4)	2575.3; (1695.6 to 3911.3)	2861.7; (2000.7 to 4093.2)	3086.6; (2194.7 to 4341.0)	2239.3; (1451.7 to 3454.4)	4668.9; (3069.6 to 7101.4)	2349.9; (1405.2 to 3929.8)	4661.9; (3401.9 to 6388.5)	4450.1; (2994.6 to 6613.0)	4004.2; (2834.4 to 5656.7)	4807.4; (3225.4 to 7165.3)	4177.3; (2914.0 to 5988.2)
Day 211	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	29 participants	39 participants	14 participants	35 participants	42 participants
																	5710.0; (3654.0 to 8922.7)	3949.0; (2991.2 to 5213.6)	4825.8; (3063.2 to 7602.6)	5389.0; (4070.1 to 7135.2)	5415.4; (3633.4 to 8071.3)
Year 2	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	24 participants	26 participants	37 participants	10 participants	32 participants	35 participants
																1513.3; (897.0 to 2553.2)	2344.8; (1508.6 to 3644.5)	1465.5; (1039.9 to 2065.3)	4160.4; (1968.6 to 8792.4)	2244.0; (1462.9 to 3442.1)	2380.4; (1507.4 to 3759.2)
Year 3	Number Analyzed	24 participants	19 participants	27 participants	26 participants	23 participants	27 participants	25 participants	28 participants	22 participants	27 participants	19 participants	25 participants	24 participants	24 participants	21 participants	24 participants	35 participants	13 participants	29 participants	37 participants
		1643.9; (850.8 to 3176.6)	1874.7; (1066.5 to 3295.6)	1756.7; (1193.6 to 2585.3)	1159.4; (731.0 to 1838.7)	1193.5; (780.4 to 1825.4)	1385.2; (946.0 to 2028.2)	1425.3; (844.2 to 2406.6)	1705.3; (1024.2 to 2839.3)	1166.5; (608.1 to 2237.6)	1775.4; (1208.6 to 2608.1)	1783.7; (1093.8 to 2909.0)	1880.8; (1254.3 to 2820.4)	2079.5; (1465.2 to 2951.4)	1946.0; (1303.7 to 2904.8)	1202.9; (682.0 to 2121.6)	2200.3; (1284.6 to 3768.8)	1771.1; (1276.4 to 2457.6)	2155.0; (1293.4 to 3590.8)	2297.5; (1422.8 to 3709.9)	2304.2; (1369.0 to 3878.4)
Year 4	Number Analyzed	23 participants	19 participants	26 participants	26 participants	23 participants	26 participants	23 participants	28 participants	22 participants	28 participants	19 participants	25 participants	23 participants	24 participants	20 participants	18 participants	22 participants	11 participants	20 participants	27 participants
		1580.2; (856.2 to 2916.6)	2128.6; (1214.1 to 3732.0)	1828.6; (1183.6 to 2825.2)	1234.2; (791.8 to 1923.6)	1283.8; (870.2 to 1894.0)	1714.5; (1133.1 to 2594.2)	2114.3; (1369.8 to 3263.4)	1858.2; (1107.6 to 3117.5)	1115.2; (597.5 to 2081.7)	1762.5; (1170.1 to 2655.0)	2173.9; (1287.5 to 3670.6)	1702.1; (976.9 to 2965.5)	2766.1; (1630.1 to 4694.0)	2044.1; (1416.3 to 2950.2)	1254.0; (743.5 to 2115.0)	1514.3; (895.9 to 2559.5)	1267.2; (788.9 to 2035.5)	1806.5; (1032.7 to 3160.1)	2466.9; (1489.0 to 4086.9)	1823.5; (1089.5 to 3052.0)
Year 5	Number Analyzed	21 participants	19 participants	26 participants	24 participants	23 participants	26 participants	24 participants	27 participants	22 participants	25 participants	19 participants	24 participants	21 participants	24 participants	19 participants	8 participants	15 participants	10 participants	10 participants	17 participants
		1159.9; (587.5 to 2289.8)	2232.6; (1270.8 to 3922.1)	1702.6; (1091.4 to 2656.0)	1135.0; (709.5 to 1815.7)	1177.1; (774.7 to 1788.5)	1545.6; (952.6 to 2507.9)	1410.6; (927.5 to 2145.5)	2047.9; (1097.6 to 3821.1)	1265.5; (682.2 to 2347.3)	2037.4; (1364.0 to 3043.1)	1648.1; (989.0 to 2746.2)	1746.6; (1149.0 to 2655.0)	2225.0; (1305.9 to 3791.0)	1624.0; (1073.2 to 2457.7)	1241.5; (726.4 to 2121.8)	1076.0; (406.2 to 2850.3)	912.7; (529.7 to 1572.6)	1187.7; (680.8 to 2071.8)	1522.7; (936.1 to 2476.8)	2097.3; (1285.7 to 3421.1)

Adverse Events

Time Frame

From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204)

Adverse Event Reporting Description

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Arm/Group Title

NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose

NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose

NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose

NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose

NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose

NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose

NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose

NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose

NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose

NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose

NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose

NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)

NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)

NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose

NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose

Arm/Group Description

Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Eligible participants who received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study.

Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.

Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.

Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.

Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.

Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.

All-Cause Mortality

NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose

NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose

NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose

NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose

NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose

NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose

NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose

NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose

NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose

NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose

NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose

NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)

NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)

NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose

NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

1/29 (3.45%)

3/39 (7.69%)

0/14 (0.00%)

2/35 (5.71%)

0/42 (0.00%)

Serious Adverse Events

NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose

NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose

NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose

NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose

NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose

NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose

NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose

NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose

NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose

NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose

NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose

NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)

NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)

NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose

NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

0/25 (0.00%)

1/19 (5.26%)

1/27 (3.70%)

1/27 (3.70%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

1/24 (4.17%)

2/29 (6.90%)

5/39 (12.82%)

0/14 (0.00%)

2/35 (5.71%)

2/42 (4.76%)

Cardiac disorders

Arteriosclerosis coronary artery † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

0/39 (0.00%)

0/14 (0.00%)

0/35 (0.00%)

1/42 (2.38%)

Cardiac failure congestive † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

1/39 (2.56%)

0/14 (0.00%)

0/35 (0.00%)

0/42 (0.00%)

Coronary artery disease † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

0/39 (0.00%)

0/14 (0.00%)

0/35 (0.00%)

1/42 (2.38%)

Eye disorders

Amaurosis fugax † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

1/29 (3.45%)

0/39 (0.00%)

0/14 (0.00%)

0/35 (0.00%)

0/42 (0.00%)

Episcleritis † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

1/24 (4.17%)

0/29 (0.00%)

0/39 (0.00%)

0/14 (0.00%)

0/35 (0.00%)

0/42 (0.00%)

Gastrointestinal disorders

Colitis ulcerative † 1

0/25 (0.00%)

1/19 (5.26%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

0/39 (0.00%)

0/14 (0.00%)

0/35 (0.00%)

0/42 (0.00%)

Crohn's disease † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

1/27 (3.70%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

0/39 (0.00%)

0/14 (0.00%)

0/35 (0.00%)

0/42 (0.00%)

Infections and infestations

Appendicitis † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

1/39 (2.56%)

0/14 (0.00%)

0/35 (0.00%)

0/42 (0.00%)

Pneumonia † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

0/39 (0.00%)

0/14 (0.00%)

1/35 (2.86%)

0/42 (0.00%)

Sepsis † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

1/39 (2.56%)

0/14 (0.00%)

0/35 (0.00%)

0/42 (0.00%)

Injury, poisoning and procedural complications

Fall † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

0/39 (0.00%)

0/14 (0.00%)

0/35 (0.00%)

1/42 (2.38%)

Subdural haematoma † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

0/39 (0.00%)

0/14 (0.00%)

1/35 (2.86%)

1/42 (2.38%)

Metabolism and nutrition disorders

Adult failure to thrive † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

0/39 (0.00%)

0/14 (0.00%)

1/35 (2.86%)

0/42 (0.00%)

Musculoskeletal and connective tissue disorders

Polymyalgia rheumatica † 1

0/25 (0.00%)

0/19 (0.00%)

1/27 (3.70%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

0/39 (0.00%)

0/14 (0.00%)

0/35 (0.00%)

0/42 (0.00%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to lung † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

1/29 (3.45%)

0/39 (0.00%)

0/14 (0.00%)

0/35 (0.00%)

0/42 (0.00%)

Metastatic renal cell carcinoma † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

1/29 (3.45%)

0/39 (0.00%)

0/14 (0.00%)

0/35 (0.00%)

0/42 (0.00%)

Squamous cell carcinoma of the tongue † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

1/39 (2.56%)

0/14 (0.00%)

0/35 (0.00%)

0/42 (0.00%)

Nervous system disorders

Neurodegenerative disorder † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

1/39 (2.56%)

0/14 (0.00%)

0/35 (0.00%)

0/42 (0.00%)

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

1/39 (2.56%)

0/14 (0.00%)

0/35 (0.00%)

0/42 (0.00%)

Respiratory failure † 1

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

0/39 (0.00%)

0/14 (0.00%)

1/35 (2.86%)

0/42 (0.00%)

1 Term from vocabulary, MedDRA24.0; † Indicates events were collected by systematic assessment

Other (Not Including Serious) Adverse Events

Frequency Threshold for Reporting Other Adverse Events

5%

NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose

NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose

NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose

NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose

NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose

NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose

NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose

NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose

NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose

NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose

NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose

NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose

NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)

NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)

NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose

NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

0/25 (0.00%)

0/19 (0.00%)

0/27 (0.00%)

0/27 (0.00%)

0/23 (0.00%)

0/27 (0.00%)

0/25 (0.00%)

0/28 (0.00%)

0/22 (0.00%)

0/28 (0.00%)

0/21 (0.00%)

0/25 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/24 (0.00%)

0/29 (0.00%)

0/39 (0.00%)

0/14 (0.00%)

0/35 (0.00%)

0/42 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: Study Director
• Organization: Takeda (Note: This product was divested to HilleVax in 2022)
• Phone: +1-877-825-3327
• EMail: trialdisclosures@takeda.com

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT03039790
• Other Study ID Numbers: NOR-213; 2016-004288-37 ( EudraCT Number ); U1111-1189-7907 ( Registry Identifier: WHO )
• First Submitted: January 31, 2017
• First Posted: February 1, 2017
• Results First Submitted: July 21, 2022
• Results First Posted: October 6, 2022
• Last Update Posted: November 9, 2022