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Clinical Trial Results:
A Phase 2, Long-Term Immunogenicity Follow-up Trial of Adult and Elderly Subjects who have Previously Received an Intramuscular Injection of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine

Summary
EudraCT number	2016-004288-37
Trial protocol	BE
Global end of trial date	22 Jul 2021

Results information
Results version number	v1(current)
This version publication date	09 Aug 2022
First version publication date	09 Aug 2022
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

NOR-213

ISRCTN number

US NCT number

NCT03039790

WHO universal trial number (UTN)

U1111-1189-7907

Sponsor organisation name

HilleVax

Sponsor organisation address

Blvd Lilienthal 42, Glattpark-Opfikon (Zurich), Switzerland, 8152

Public contact

Paul Bavier, HilleVax, +1 6172063351, pbavier@hillevax.com

Scientific contact

Astrid Borkowski, HilleVax, +41 (0) 799069941, aborkowski@hillevax.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

04 Jul 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

22 Jul 2021

Was the trial ended prematurely?

Main objective of the trial

The main objective of the trial is to evaluate the humoral response after at least 1 dose of NoV vaccine up to 5 years after intramuscular (IM injection as measured by histo-blood group antigen (HBGA) blocking assay.

Protection of trial subjects

All the participants were required to read and sign the Informed Consent Form (ICF).

Background therapy

Evidence for comparator

Actual start date of recruitment

20 Feb 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 183

Country: Number of subjects enrolled

Belgium: 345

Worldwide total number of subjects

528

EEA total number of subjects

345

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

405

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Participants took part in the study at 11 investigational sites in Belgium (9 sites) and the United States (2 sites) from 21 February 2017 to 22 July 2021.

Screening details

Healthy volunteers who previously received NoV vaccine in studies NOR-107 (NCT02038907), NOR-210 (NCT02475278) and NOR-204 (NCT02661490) were assessed in this study for up to 5 years. No additional doses of vaccine were administered.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

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

Arm 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.

Arm type

Experimental

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

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

Arm description

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 MLP and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

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

Arm description

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 MLP and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

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

Arm description

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 MLP and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

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

Arm description

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 MLP and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Arm type

Experimental

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

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

Arm description

Eligible NOR-107 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, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Arm type

Experimental

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

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

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

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

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

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

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

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

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

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

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

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

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

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

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

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

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

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

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

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

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

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

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

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

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

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

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

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

Arm description

Eligible NOR-204 participants who had received Norovirus bivalent VLP 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.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Number of subjects in period 1	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, 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 (15/50/500/15) µg - MPL 15 µg, 2-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
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)	25	19	27	26	23	27	25	28	22	28	19 ^[1]	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
Withdrawal of Consent	1	-	-	1	-	-	-	-	-	1	-	-	2	-	1	5	3	-	2	5
Adverse event, serious fatal	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1	3	-	2	-
Reason, not Specified	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	2	-	1	-
Lost to follow-up	2	-	1	1	-	1	1	1	-	1	1	-	1	-	3	1	2	2	1	3

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Per Protocol Set (PPS) included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint.

Baseline characteristics

Top of page

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

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.

Reporting group title

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

Reporting group description

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.

Reporting group title

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

Reporting group description

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.

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

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.

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group values	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, 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 (15/50/500/15) µg - MPL 15 µg, 2-Dose	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose	Total
Number of subjects	25	19	27	27	23	27	25	28	22	28	21	25	24	24	24	29	39	14	35	42
Age Categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	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 )	-
Gender categorical
Units: Subjects
Female	16	13	19	20	14	21	12	14	16	21	12	15	18	16	10	20	19	7	18	23	324
Male	9	6	8	7	9	6	13	14	6	7	9	10	6	8	14	9	20	7	17	19	204
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	1	2	1	3	3	15
Not Hispanic or Latino	0	0	0	0	0	0	0	0	0	0	0	0	0	0	19	28	37	13	32	39	168
Unknown or Not Reported	25	19	27	27	23	27	25	28	22	28	21	25	24	24	0	0	0	0	0	0	345
Race (NIH/OMB)
Units: Subjects
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
Asian	0	0	0	1	0	1	0	0	0	1	0	0	0	0	0	0	1	0	0	0	4
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1
Black or African American	0	0	0	0	0	0	0	0	0	0	0	0	0	0	7	1	0	1	0	3	12
White	25	19	27	26	23	26	25	28	22	27	21	25	24	24	16	28	38	12	35	39	510
More than one race	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1
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

End points

Top of page

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

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.

Reporting group title

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

Reporting group description

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.

Reporting group title

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

Reporting group description

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.

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

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.

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Primary: Geometric Mean Blocking Titers 50 percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as measured by Histo-Blood Group Antigen (HBGA) blocking assay

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End point 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 ^[1]

End point description

GMBT50 of anti-norovirus GI. VLP antibody titers as measured by HBGA blocking assay. Data reported for up to Year 5 was collected at Baseline,Days 28,29,36,56,57,208,211 Year 2,3,4, and 5.PPS=all participants in the FAS who had no major or critical protocol violations.n=number of participants with data available for analysis at specific timepoints.Baseline(n=25,19,27,26,23,27,25,28,22,28,19,25,24,24,24,29,39,14,35,42)D28(n=25,19,26,26,23,27,25,28,21,28,19,25,24,24)D29(n=24,29,39,14,35,42)D36(n=29,39,14,35,42)D56(n=25,19,27,26,23,27,25,28,22,28,19,25,24,24)D57(n=29,39,14,35,42)D208(n=25,19,27,26,23,27,25,28,22,28,19,25,24,24)D211(n=29,39,14,35,42)Y2(n=24,26,37,10,32,34)Y3(n=24,19,27,26,23,26,25,28,22,27,19,25,24,24,21,24,35,13,29,37)Y4(n=23,19,26,26,23,26,23,28,22,28,19,25,23,24,20,18,22,11,20,27)Y5(n=21,19,26,24,23,26,24,27,22,25,19,24,21,24,19,8,13,10,10,16).999,9999,99999=No participants were analyzed at specific timepoints in NOR-107,NOR-210,NOR-204 study respectively.

End point type

Primary

End point timeframe

Up to 5 years post-primary vaccination

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this primary endpoint.

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, 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 (15/50/500/15) µg - MPL 15 µg, 2-Dose

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

Number of subjects analysed

Units: titer

geometric mean (confidence interval 95%)

Baseline

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)

Day 28

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)

9999 (-9999 to 9999)

99999 (-99999 to 99999)

Day 29

999 (-999 to 999)

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

999 (-999 to 999)

9999 (-9999 to 9999)

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

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)

9999 (-9999 to 9999)

99999 (-99999 to 99999)

Day 57

999 (-999 to 999)

9999 (-9999 to 9999)

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

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)

9999 (-9999 to 9999)

99999 (-99999 to 99999)

Day 211

999 (-999 to 999)

9999 (-9999 to 9999)

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

999 (-999 to 999)

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

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

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

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)

No statistical analyses for this end point

Primary: Geometric mean blocking titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as measured by HBGA blocking assay

Top of page

End point title

Geometric mean blocking titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as measured by HBGA blocking assay ^[2]

End point description

GMBT50 of anti-norovirus GII. VLP antibody titers as measured by HBGA blocking assay.Data reported for up to Year 5 was collected at Baseline,Days 28,29,36,56,57,208,211 Year 2,3,4, and 5.PPS=all participants in FAS who had no major or critical protocol violations.n=number of participants with data available for analysis at specific timepoints.Baseline (n=25,19,27,26,23,27,25,28,22,28,19,25,24,24,24,29,39,14,35,42) D28 (n=25,19,26,26,23,27,25,28,21,28,19,25,24,24)D29 (n=24,29,39,14,35,42) D36 (n=29,39,14,35,42) D56 (n=25,19,27,26,23,27,25,28,22,28,19,25,24,24)D57 (n=29,39,14,35,42) D208 (n=25,19,27,26,23,27,25,28,22,28,19,25,24,24) D211 (n=29,39,14,35,42) Y2 (n=24,26,37,10,32,35) Y3 (n=24,19,27,26,23,27,25,28,22,27,19,25,24,24,21,24,35,13,29,37) Y4 (n=23,19,26,26,23,26,23,28,22,28,19,25,23,24,20,18,22,11,20,27) Y5 (n=21,19,26,24,23,26,24,27,22,25,19,24,21,24,19,8,14,10,10,17).999,9999,99999=No participants were analyzed at specific timepoints in NOR-107,NOR-210,NOR-204 respectively.

End point type

Primary

End point timeframe

Up to 5 years post-primary vaccination

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this primary endpoint.

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, 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 (15/50/500/15) µg - MPL 15 µg, 2-Dose

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

Number of subjects analysed

Units: titer

geometric mean (confidence interval 95%)

Baseline

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

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)

9999 (-9999 to 9999)

99999 (-99999 to 99999)

Day 29

999 (-999 to 999)

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

999 (-999 to 999)

9999 (-9999 to 9999)

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

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)

9999 (-9999 to 9999)

99999 (-99999 to 99999)

Day 57

999 (-999 to 999)

9999 (-9999 to 9999)

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

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)

9999 (-9999 to 9999)

99999 (-99999 to 99999)

Day 211

999 (-999 to 999)

9999 (-9999 to 9999)

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

999 (-999 to 999)

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

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

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

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)

No statistical analyses for this end point

Secondary: Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as measured by Total Immunoglobulin (pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)

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End point title

Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as measured by Total Immunoglobulin (pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)

End point description

GMT of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA.Data reported for up to Year 5 was collected at Baseline,Days 28,29,36,56,57,208,211 Year 2,3,4, and 5.PPS=all participants in FAS who had no major or critical protocol violations.n=number of participants with data available for analysis at specific timepoints.Baseline (n=25,19,27,26,23,27,25,28,22,28,19,25,24,24,24,29,39,14,35,42) D28 (n=25,19,26,26,23,27,25,28,21,28,19,25,24,24) D29 (n=24,29,39,14,35,42) D36 (n=29,39,14,35,42) D56 (n=25,19,27,26,23,27,25,28,22,28,19,25,24,24) D57 (n=29,39,14,35,42 D208 (n=25,19,27,26,23,27,25,28,22,28,19,25,24,24) D211 (n=29,39,14,35,42) Y2 (n=24,26,37,10,32,35) Y3 (n=24,19,27,26,23,27,25,28,22,27,19,25,24,24,21,24,35,13,29,37) Y4 (n=23,19,26,26,23,26,23,28,22,28,19,25,23,24,20,18,22,11,20,27) Y5 (n=21,19,26,24,23,26,24,27,22,25,19,24,21,24,19,8,15,10,10,16).999,9999,99999=No participants were analyzed at specific timepoints in NOR-107,NOR-210,NOR-204 respectively.

End point type

Secondary

End point timeframe

Up to 5 years post-primary vaccination

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, 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 (15/50/500/15) µg - MPL 15 µg, 2-Dose

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

Number of subjects analysed

Units: titer

geometric mean (confidence interval 95%)

Baseline

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

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)

9999 (-9999 to 9999)

99999 (-99999 to 99999)

Day 29

999 (-999 to 999)

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

999 (-999 to 999)

9999 (-9999 to 9999)

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

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)

9999 (-9999 to 9999)

99999 (-99999 to 99999)

Day 57

999 (-999 to 999)

9999 (-9999 to 9999)

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

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)

9999 (-9999 to 9999)

99999 (-99999 to 99999)

Day 211

999 (-999 to 999)

9999 (-9999 to 9999)

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

999 (-999 to 999)

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

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

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

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)

No statistical analyses for this end point

Secondary: Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as measured by pan-Ig ELISA

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End point title

Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as measured by pan-Ig ELISA

End point 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,Days 28,29,36,56,57,208,211 Year 2,3,4, and 5.PPS=all participants in FAS who had no major or critical protocol violations.n=number of participants with data available for analysis at specific timepoints. Baseline (n=25,19,27,26,23,27,25,28,22,28,19,25,24,24,24,29,39,14,35,42) D28 (n=25,19,26,26,23,27,25,28,21,28,19,25,24,24) D29 (n=24,29,39,14,35,42) D36 (n=29,39,14,35,42) D56 (n=25,19,27,26,23,27,25,28,22,28,19,25,24,24) D57 (n=29,39,14,35,42) D208 (n=25,19,27,26,23,27,25,28,22,28,19,25,24,24) D211 (n=29,39,14,35,42) Y2 (n=24,26,37,10,32,35) Y3 (n=24,19,27,26,23,27,25,28,22,27,19,25,24,24,21,24,35,13,29,37) Y4 (n=23,19,26,26,23,26,23,28,22,28,19,25,23,24,20,18,22,11,20,27) Y5 (n=21,19,26,24,23,26,24,27,22,25,19,24,21,24,19,8,15,10,10,17). 999,9999,99999=No participants were analyzed at specific timepoints in NOR-107,NOR-210,NOR-204 respectively.

End point type

Secondary

End point timeframe

Up to 5 years post-primary vaccination

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, 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 (15/50/500/15) µg - MPL 15 µg, 2-Dose

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

Number of subjects analysed

Units: titer

geometric mean (confidence interval 95%)

Baseline

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

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)

9999 (-9999 to 9999)

99999 (-99999 to 99999)

Day 29

999 (-999 to 999)

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

999 (-999 to 999)

9999 (-9999 to 9999)

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

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)

9999 (-9999 to 9999)

99999 (-99999 to 99999)

Day 57

999 (-999 to 999)

9999 (-9999 to 9999)

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

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)

9999 (-9999 to 9999)

99999 (-99999 to 99999)

Day 211

999 (-999 to 999)

9999 (-9999 to 9999)

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

999 (-999 to 999)

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

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

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

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)

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

From the time of informed consent signed up to end of the study (Up to approximately 5 years)

Adverse event reporting additional 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.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

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.

Reporting group title

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

Reporting group description

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.

Reporting group title

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

Reporting group description

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.

Reporting group title

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

Reporting group description

Eligible NOR-217 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.

Reporting group title

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

Reporting group description

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.

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Eligible NOR-217 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.

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Reporting group title

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

Reporting group description

Notes
[1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
Justification: No non-serious adverse events were reported in this study.

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

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

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

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

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

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

Total subjects affected by serious adverse events

subjects affected / exposed

1 / 27 (3.70%)

0 / 25 (0.00%)

1 / 19 (5.26%)

1 / 27 (3.70%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

1 / 24 (4.17%)

2 / 35 (5.71%)

0 / 14 (0.00%)

5 / 39 (12.82%)

2 / 29 (6.90%)

2 / 42 (4.76%)

number of deaths (all causes)

number of deaths resulting from adverse events

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

Metastases to lung

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 39 (0.00%)

1 / 29 (3.45%)

0 / 42 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metastatic renal cell carcinoma

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 39 (0.00%)

1 / 29 (3.45%)

0 / 42 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Squamous cell carcinoma of the tongue

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

1 / 39 (2.56%)

0 / 29 (0.00%)

0 / 42 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Fall

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 39 (0.00%)

0 / 29 (0.00%)

1 / 42 (2.38%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Subdural haematoma

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 39 (0.00%)

0 / 29 (0.00%)

1 / 42 (2.38%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Arteriosclerosis coronary artery

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 39 (0.00%)

0 / 29 (0.00%)

1 / 42 (2.38%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Cardiac failure congestive

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

1 / 39 (2.56%)

0 / 29 (0.00%)

0 / 42 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Coronary artery disease

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 39 (0.00%)

0 / 29 (0.00%)

1 / 42 (2.38%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Nervous system disorders

Neurodegenerative disorder

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

1 / 39 (2.56%)

0 / 29 (0.00%)

0 / 42 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Eye disorders

Amaurosis fugax

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 39 (0.00%)

1 / 29 (3.45%)

0 / 42 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Episcleritis

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

1 / 24 (4.17%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 39 (0.00%)

0 / 29 (0.00%)

0 / 42 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Colitis ulcerative

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

1 / 19 (5.26%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 39 (0.00%)

0 / 29 (0.00%)

0 / 42 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Crohn's disease

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

1 / 27 (3.70%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 39 (0.00%)

0 / 29 (0.00%)

0 / 42 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

1 / 39 (2.56%)

0 / 29 (0.00%)

0 / 42 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory failure

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 39 (0.00%)

0 / 29 (0.00%)

0 / 42 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Polymyalgia rheumatica

subjects affected / exposed

1 / 27 (3.70%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 39 (0.00%)

0 / 29 (0.00%)

0 / 42 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Appendicitis

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

1 / 39 (2.56%)

0 / 29 (0.00%)

0 / 42 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 39 (0.00%)

0 / 29 (0.00%)

0 / 42 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Sepsis

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

1 / 39 (2.56%)

0 / 29 (0.00%)

0 / 42 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Adult failure to thrive

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 39 (0.00%)

0 / 29 (0.00%)

0 / 42 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

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

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

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

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

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

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

Total subjects affected by non serious adverse events

subjects affected / exposed

0 / 27 (0.00%)

0 / 25 (0.00%)

0 / 19 (0.00%)

0 / 27 (0.00%)

0 / 23 (0.00%)

0 / 27 (0.00%)

0 / 22 (0.00%)

0 / 25 (0.00%)

0 / 28 (0.00%)

0 / 24 (0.00%)

0 / 25 (0.00%)

0 / 21 (0.00%)

0 / 24 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 39 (0.00%)

0 / 29 (0.00%)

0 / 42 (0.00%)

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A Phase 2, Long-Term Immunogenicity Follow-up Trial of Adult and Elderly Subjects who have Previously Received an Intramuscular Injection of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Geometric Mean Blocking Titers 50 percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as measured by Histo-Blood Group Antigen (HBGA) blocking assay

Primary: Geometric Mean Blocking Titers 50 percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as measured by Histo-Blood Group Antigen (HBGA) blocking assay

Primary: Geometric mean blocking titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as measured by HBGA blocking assay

Primary: Geometric mean blocking titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as measured by HBGA blocking assay

Secondary: Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as measured by Total Immunoglobulin (pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)

Secondary: Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as measured by Total Immunoglobulin (pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)

Secondary: Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as measured by pan-Ig ELISA

Secondary: Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as measured by pan-Ig ELISA

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase 2, Long-Term Immunogenicity Follow-up Trial of Adult and Elderly Subjects who have Previously Received an Intramuscular Injection of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Geometric Mean Blocking Titers 50 percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as measured by Histo-Blood Group Antigen (HBGA) blocking assay

Primary: Geometric Mean Blocking Titers 50 percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as measured by Histo-Blood Group Antigen (HBGA) blocking assay

Primary: Geometric mean blocking titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as measured by HBGA blocking assay

Primary: Geometric mean blocking titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as measured by HBGA blocking assay

Secondary: Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as measured by Total Immunoglobulin (pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)

Secondary: Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as measured by Total Immunoglobulin (pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)

Secondary: Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as measured by pan-Ig ELISA

Secondary: Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as measured by pan-Ig ELISA

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 2, Long-Term Immunogenicity Follow-up Trial of Adult and Elderly Subjects who have Previously Received an Intramuscular Injection of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine