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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

    Close Top of page
    Trial identification
    Sponsor protocol code
    NOR-213
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03039790
    WHO universal trial number (UTN)
    U1111-1189-7907
    Sponsors
    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
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Jul 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    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
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    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
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    405
    From 65 to 84 years
    86
    85 years and over
    37

    Subject disposition

    Close Top of page
    Recruitment
    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.

    Pre-assignment
    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
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    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)

    Arm title
    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

    Arm title
    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

    Arm title
    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

    Arm title
    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)

    Arm title
    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)

    Arm title
    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

    Arm title
    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)

    Arm title
    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

    Arm title
    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

    Arm title
    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)

    Arm title
    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

    Arm title
    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

    Arm title
    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

    Arm title
    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

    Arm title
    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)

    Arm title
    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)

    Arm title
    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)

    Arm title
    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)

    Arm title
    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

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    Baseline characteristics reporting groups
    Reporting group title
    NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose
    Reporting 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.

    Reporting group title
    NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 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 50 µg MLP and 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- MPL 50 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 50 µg MLP and 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 (15/15/500) μg- MPL 15 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 15 µg MLP and 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- MPL 15 μg,1-Dose
    Reporting group 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.

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

    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
    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.

    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
    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.

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

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

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

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

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

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

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

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

    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

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    End points reporting groups
    Reporting group title
    NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose
    Reporting 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.

    Reporting group title
    NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 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 50 µg MLP and 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- MPL 50 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 50 µg MLP and 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 (15/15/500) μg- MPL 15 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 15 µg MLP and 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- MPL 15 μg,1-Dose
    Reporting group 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.

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

    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
    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.

    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
    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.

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

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

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

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

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

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

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

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

    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.
    End point 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
    Number of subjects analysed
    25
    19
    27
    26
    23
    27
    25
    28
    22
    28
    19
    25
    24
    24
    24
    29
    39
    14
    35
    42
    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)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Day 29
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Day 57
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Day 211
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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

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    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.
    End point 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
    Number of subjects analysed
    25
    19
    27
    26
    23
    27
    25
    28
    22
    28
    19
    25
    24
    24
    24
    29
    39
    14
    35
    42
    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)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Day 29
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Day 57
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Day 211
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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
    End point 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
    Number of subjects analysed
    25
    19
    27
    26
    23
    27
    25
    28
    22
    28
    19
    25
    24
    24
    24
    29
    39
    14
    35
    42
    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)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Day 29
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Day 57
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Day 211
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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
    End point 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
    Number of subjects analysed
    25
    19
    27
    26
    23
    27
    25
    28
    22
    28
    19
    25
    24
    24
    24
    29
    39
    14
    35
    42
    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)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Day 29
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Day 57
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Day 211
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    999 (-999 to 999)
    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

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    Adverse events information [1]
    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 used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 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 50 µg MLP and 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 (15/15/500) μg- MPL 50 μg,1-Dose
    Reporting 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.

    Reporting group title
    NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 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 50 µg MLP and 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 (15/15/500) μg- MPL 15 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 15 µg MLP and 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- MPL 15 μg,1-Dose
    Reporting group 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.

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

    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
    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.

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

    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
    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.

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

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

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

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

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

    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.
    Serious adverse events
    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 / 28 (0.00%)
    0 / 24 (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)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    3
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    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 / 28 (0.00%)
    0 / 24 (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 / 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
    0 / 0
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 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
    0 / 0
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 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
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 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
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 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
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 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
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 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
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 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
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 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
    0 / 0
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 0
    0 / 1
    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
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 0
    0 / 0
    0 / 1
    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
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 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
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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
    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
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 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
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 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
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    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
    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 / 28 (0.00%)
    0 / 24 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    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 / 28 (0.00%)
    0 / 24 (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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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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