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    Summary
    EudraCT Number:2016-004288-37
    Sponsor's Protocol Code Number:NOR-213
    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:2017-02-14
    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 number2016-004288-37
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Follow-up Trial of Adult and Elderly Subjects who have Previously Received an Intramuscular Injection of Norovirus GI.1/GII.4 Bivalent
    Virus- Vaccine
    A.4.1Sponsor's protocol code numberNOR-213
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/125/2015
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Vaccines, 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, 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 pointJakob P. Cramer
    B.5.3 Address:
    B.5.3.1Street AddressThurgauerstrasse 130
    B.5.3.2Town/ cityGlattpark-Opfikon (Zurich)
    B.5.3.3Post code8152
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number41445551623
    B.5.5Fax number4144 555 1445
    B.5.6E-mailJakob.Cramer@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 INNN/A
    D.3.9.2Current sponsor codePer IMPD (2013-001419-64)
    D.3.9.3Other descriptive namePer IMPD (2013-001419-64)
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 300
    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 Yes
    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
    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
    E.1.1.1Medical condition in easily understood language
    Follow-up study of adult and Elderly Subjects who have Previously Received an Injection of Norovirus Vaccine
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10062371
    E.1.2Term Active immunization
    E.1.2System Organ Class 100000022894
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the humoral response after at least 1 dose of NoV vaccine up to 5 years after IM injection as measured by histo-blood group antigen (HBGA) blocking assay.
    E.2.2Secondary objectives of the trial
    To evaluate the humoral response after at least 1 dose of NoV vaccine up to 5 years after IM injection as measured by total-immunoglobulin (pan-Ig) enzyme-linked immunosorbent assay (ELISA)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject is aged over 18 years.
    2. Male and female subjects who previously received at least 1 dose of NoV vaccine in trials NOR-107, NOR-210, NOR-204 and NOR-222, have baseline and post-vaccination data, and completed the primary vaccination trial protocol as initially described.
    3. The subject signs and dates a written, informed consent form (ICF) 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.
    4. Individuals who can comply with trial procedures and are available for the duration of follow-up
    E.4Principal exclusion criteria
    Any subject who meets any of the following criteria will not qualify for entry into the trial:
    1. Participation in any clinical trial is allowed, on condition that no investigational product is administered within 30 days prior to blood sampling.
    2. In the opinion of the investigator, the subject is not medically eligible to provide blood specimens.
    3. Individuals with behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject’s ability to participate in the trial.
    There may be instances when individuals meet all entry criteria except one that relates to transient clinical circumstances (e.g., temperature elevation or recent vaccine). Under these circumstances,
    eligibility for trial enrolment may be considered if the appropriate window for delay has passed, inclusion/exclusion criteria have been rechecked, and if the subject is confirmed to be eligible.
    E.5 End points
    E.5.1Primary end point(s)
    - Geometric Mean Blocking Titers (GMBT50) of anti-norovirus GI.1 VLP antibodies.
    - GMBT50 of anti-norovirus GII.4 VLP antibodies.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Yearly intervals from at least 1 year and up to 5 years after primary vaccination.
    E.5.2Secondary end point(s)
    The secondary endpoints (immunogenicity) for this trial, as measured by pan-Ig ELISA are:
    - Geometric Mean Titers (GMT) of anti-norovirus GI.1 VLP antibodies.
    - GMT of GII.4 VLP antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    Yearly intervals from at least 1 year and up to 5 years after primary vaccination.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    United States
    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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 550
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Follow-up in healthy subjects in stable health conditions. No IMP administered
    F.4 Planned number of subjects to be included
    F.4.1In the member state350
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 800
    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)
    No IMP is being administered in this study. Subjects will continue on their normal care during and after the study.
    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 Decision2017-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-07-22
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