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    Summary
    EudraCT Number:2013-001419-64
    Sponsor's Protocol Code Number:NOR-107
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-04
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-001419-64
    A.3Full title of the trial
    A Phase II, Randomized, Controlled, Double-Blind, Dosage and Adjuvant Justification, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Adjuvanted with or without Monophosphoryl Lipid A and Aluminum Hydroxide in Adolescents and Adults
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A norovirus vaccine study
    A.3.2Name or abbreviated title of the trial where available
    NOR-107 Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine
    A.4.1Sponsor's protocol code numberNOR-107
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Vaccines (Montana), Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTakeda Vaccines (Montana), Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Pharmaceuticals International GmbH
    B.5.2Functional name of contact pointFrank Baehner
    B.5.3 Address:
    B.5.3.1Street AddressThurgauerstrasse 130
    B.5.3.2Town/ city Glattpark-Opfikon (Zurich)
    B.5.3.3Post code8152
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number41445551520
    B.5.5Fax number4144 555 1445
    B.5.6E-mailFrank.Baehner@takeda.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNorovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeGI.1 NV-VLP
    D.3.9.3Other descriptive nameGI.1 NV-VLP
    D.3.10 Strength
    D.3.10.1Concentration unit µg/l microgram(s)/litre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15 to 50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeGII.4 C-VLP
    D.3.9.3Other descriptive nameGII.4 C-VLP
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15 to 50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Havrix Monodose Vaccine
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline UK
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHavrix® Monodose® Vaccine
    D.3.2Product code Havrix® Monodose® Vaccine
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHavrix® Monodose® Vaccine
    D.3.9.2Current sponsor codeHavrix® Monodose® Vaccine
    D.3.9.3Other descriptive nameHavrix® Monodose® Vaccine
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of gastroenteritis caused by norovirus
    E.1.1.1Medical condition in easily understood language
    Prevention of gastroenteritis caused by norovirus
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10068189
    E.1.2Term Gastroenteritis norovirus
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To select the optimal formulation of the investigational vaccine from different concentrations of VLP and MPL adjuvant for further development:
    - By assessing the seroresponse rate (≥4-fold rise) of serum anti-norovirus GI.1 VLP and GII.4 VLP antibody titers by Pan-Ig enzyme-linked immunosorbent assay (ELISA) at Day 56.
    - By assessing the safety profile of different formulations of the investigational vaccine as measured by solicited local and systemic adverse events (AEs) for the period of 7 days after each vaccination (including the day of vaccination) and as measured by the occurrence of unsolicited AEs 28 days after each vaccination and Serious Adverse Events (SAEs) throughout the trial.
    E.2.2Secondary objectives of the trial
    To evaluate:
    GMT & GMFR of anti-norovirus GI.1 VLP and GII.4 VLP AB titers Percentage of subjects with 4-fold rise or > of serum anti-norovirus GI.1 VLP and/or GII.4 VLP AB titers.
    GMT and GMFR of anti-norovirus GI.1 VLP and GII.4 VLP AB titers
    Percentage of subjects with a 4-fold rise or > of serum anti-norovirus GI.1 VLP and/or GII.4 VLP AB titers
    BT50 & GMFR of serum anti-norovirus AB titers for GI.1 VLP and GII.4 VLP as measured by the HBGA binding assay at Day 28, 56, 208 & 393.
    Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GI.1 VLP and/or GII.4 VLP AB blocking titers
    BT50 and GMFR of serum anti-norovirus AB titers of a panel of GI.1 and GII.4 not represented in the vaccine
    To assess safety by the occurrence of Significant New Medical Conditions and unsolicited AEs leading to subject's withdrawal from the trial throughout the trial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female subjects between 17 and 64 years of age at the time of enrollment.
    - Subjects who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator.
    - The subject or, when applicable, the subject’s legally acceptable representative signs and dates a written, informed consent form (and assent form in the case of adolescents) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
    - Subjects who can comply with trial procedures and are available for the duration of the trial.
    E.4Principal exclusion criteria
    - Subjects who have received any vaccination that included Hepatitis A vaccine within the last 5 years.
    - Subjects with known hypersensitivity to any of the vaccine components.
    - Subjects with contraindications, warnings, and/or precautions to vaccinations with Havrix.
    - Subjects with known or suspected impairment/alteration of immune function.
    - Female subjects who are pregnant or breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity
    Seroresponse rate, defined as percentage of subjects with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by Pan-Ig ELISA at Day 56.

    Safety
    - Percentage of subjects with solicited local AEs at injection site: pain, erythema, induration, and swelling for 7 days after each vaccination (including the day of vaccination).
    -Percentage of subjects with solicited systemic AEs - headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea for 7 days after each vaccination (including the day of vaccination).
    - Oral body temperature for 7 days after each vaccination (including the day of vaccination).
    - Percentage of subjects with any unsolicited AEs - From Day 1 (postvaccination) through Day 56 (28 days after the second vaccination) inclusive.
    - Percentage of subjects with SAEs throughout the trial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 56
    E.5.2Secondary end point(s)
    The secondary endpoints for this trial are as follows (note that immunogenicity analyses at Day 28 apply only to the 2 dose groups):
    Immunogenicity
    Pan-Ig ELISA
    - Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GI.1 VLP and GII.4 VLP antibody titers as measured by Pan-Ig ELISA on Day 28, Day 208, and Day 393.
    - Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GI.1 VLP antibody titers as measured by Pan-Ig ELISA on Day 28, Day 56, Day 208, and Day 393.
    - Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GII.4 VLP antibody titers as measured by Pan-Ig ELISA on Day 28, Day 56, Day 208, and Day 393.
    - GMT of anti-norovirus GI.1 VLP antibody titers as measured by Pan-Ig ELISA on Day 28, Day 56, Day 208, and Day 393.
    - GMT of anti-norovirus GII.4 VLP antibody titers as measured by Pan-Ig ELISA on Day 28, Day 56, Day 208, and Day 393.
    - GMFR of anti-norovirus GI.1 VLP antibody titers as measured by Pan-Ig ELISA on Day 28, Day 56, Day 208, and Day 393.
    - GMFR of anti-norovirus GII.4 VLP antibody titers as measured by Pan-Ig ELISA on Day 28, Day 56, Day 208, and Day 393.
    IgA ELISA
    - Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GI.1 VLP and GII.4 VLP antibody titers as measured by IgA ELISA on Day 28, Day 56, Day 208, and Day 393.
    - Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA on Day 28, Day 56, Day 208, and Day 393.
    - Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA on Day 28, Day 56, Day 208, and Day 393.
    - GMT of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA on Day 28, Day 56, Day 208, and Day 393.
    - GMT of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA on Day 28, Day 56, Day 208, and Day 393.
    GMFR of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA on Day 28, Day 56, Day 208, and Day 393.
    - GMFR of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA on Day 28, Day 56, Day 208, and Day 393.
    HBGA Binding Assay
    - Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GI.1 VLP and GII.4 VLP antibody titers as measured by HBGA binding assay on Day 28, Day 56, Day 208, and Day 393.
    - Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay on Day 28, Day 56, Day 208, and Day 393.
    - Percentage of subjects with a 4-fold rise or greater of serum anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay on Day 28, Day 56, Day 208, and Day 393.
    - BT50 of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay on Day 28, Day 56, Day 208, and Day 393.
    - BT50 of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay on Day 28, Day 56, Day 208, and Day 393.
    - GMFR of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay on Day 28, Day 56, Day 208, and Day 393.
    - GMFR of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay on Day 28, Day 56, Day 208, and Day 393.
    - GMFR and BT50 of anti-norovirus antibody titers of strains not represented in the investigational vaccine as measured by HBGA binding assay on Day 28, Day 56, Day 208, and Day 393
    Safety
    - Percentage of subjects with Significant New Medical Conditions (AESIs and IMEs) throughout the trial.
    - Percentage of subjects with any AE leading to subject’s withdrawal from the trial throughout the trial.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 28, Day 56, Day 208, and Day 393
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Vaccine. One time adminstration only
    E.8.2.4Number of treatment arms in the trial11
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 20
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state420
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 420
    F.4.2.2In the whole clinical trial 420
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
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