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    Summary
    EudraCT Number:2014-000778-20
    Sponsor's Protocol Code Number:NOR-202
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-10-26
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-000778-20
    A.3Full title of the trial
    A Phase II, Randomized, Double-Blind, Dosage, Safety and Immunogenicity Trial of
    Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine combined with
    Aluminum Hydroxide adjuvant in Children, Toddlers, and Infants
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A norovirus vaccine study in children
    A.3.2Name or abbreviated title of the trial where available
    NOR-202 Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine in Children
    A.4.1Sponsor's protocol code numberNOR-202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02153112
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1154-9733
    A.7Trial is part of a Paediatric Investigation Plan Yes
    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 Vaccines, Inc.
    B.5.2Functional name of contact pointTaisei Masuda
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+4144555 1479
    B.5.6E-mailtaisei.masuda@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 Suspension for 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 150
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntramuscular use
    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 20.1
    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 NoV bivalent VLP vaccine from different dosages of VLP for further development:
    * By assessing the seroresponse rate (percentage of subjects with ≥4-fold rises) in serum anti-NoV GI.1 VLP and GII.4 VLP antibody titers by Pan immunoglobin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).
    * By assessing the safety profile of different formulations of the NoV bivalent VLP vaccine as measured by solicited local and systemic adverse events (AEs) for the period of 7 days after each 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 the geometric mean titers (GMT) and GMFRs of anti-NoV GI.1 VLP and GII.4 VLP antibody titers as measured by Pan-Ig ELISA.
    * To evaluate the seroresponse rate in serum anti-NoV GI.1 VLP and/or GII.4 VLP antibody blocking titers as measured by histoblood group antigen (HBGA) binding assay.
    * To evaluate Geometric Mean Blocking Titers (BT50) and GMFR of serum anti-NoV antibody titers for GI.1 VLP and GII.4 VLP as measured by the HBGA binding assay.
    * To assess safety by the incidence of 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 aged between 6 weeks and less than 9 years 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’s legally acceptable representative 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. An assent will also be obtained according to age appropriate country-specific regulations.
    * Individuals who can comply with trial procedures and are available for the duration of the trial.
    E.4Principal exclusion criteria
    1. Subjects with a clinically significant active infection (as assessed by
    the investigator) or body temperature 38.0°C (100.4°F) or higher within
    3 days of the intended date of vaccination.
    2. Subjects who have received antipyretic/analgesic medications within
    24 hours prior to the intended vaccine administration.
    3. Known hypersensitivity or allergy to investigational vaccine
    4. Subjects with behavioral 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.
    5. Subjects with a history of any progressive or severe neurologic
    disorder, seizure disorder, or neuroinflammatory disease (eg, Guillain-Barre syndrome).
    6. Known or suspected impairment/alteration of immune function,
    including the following:
    a. Children <18 months of age with history of repeated episodes of acute
    otitis media (AOM) in the first 6 months of life (AOM defined as a bulging
    tympanic membrane) and not to be confused with otitis media with
    effusion (OME).
    b. Chronic use of oral steroids (equivalent to 20 mg/day prednisone for
    ≥12 weeks/≥2 mg/kg body weight/day for ≥2 weeks) within 60 days
    prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is
    allowed).
    c. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥ 12 weeks/≥ 2 mg/kg body weight/day for ≥ 2 weeks) within 60 days prior to Day 1.
    d. Receipt of immunostimulants within 60 days prior to Day 1.
    e. Receipt of parenteral, epidural, or intra-articular immunoglobulin
    preparation, blood products, and/or plasma derivatives within 3 months
    prior to Day 1 or planned during the full length of the trial.
    f. Receipt of immunosuppressive therapy within 6 months prior to Day 1.
    g. Human immunodeficiency virus (HIV) infection or HIV-related
    disease.
    h. Chronic Hepatitis B or C infection.
    i. Heritable immunodeficiency.
    7. Abnormalities of splenic or thymic function.
    8. Subjects with a known bleeding diathesis or any condition that may be
    associated with a prolonged bleeding time.
    9. Subjects with any serious chronic or progressive disease according to
    judgment of the investigator (eg, neoplasm, insulin dependent diabetes,
    cardiac, renal, or hepatic disease).
    10. Subjects participating in any clinical trial with another
    investigational product 30 days prior to first trial visit or intent to
    participate in another clinical trial at any time during the conduct of this
    trial.
    11. Subjects who received any other vaccines within 14 days (for
    inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in
    this trial.
    12. Subjects who are first degree relatives of individuals involved in trial conduct.
    13. Subjects with a history of autoimmune disease.
    14. There may be instances when individuals meet all entry criteria
    except one that relates to transient clinical circumstances (eg, body
    temperature elevation or recent use of excluded medication or vaccine).
    Under these circumstances, a subject may be considered eligible for trial
    enrollment 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)
    Immunogenicity
    • Seroresponse rate (defined as percentage of subjects with a 4-fold rise or greater) in serum anti-NoV antibody titers for both GI.1 VLP and GII.4 VLP as measured by Pan-Ig ELISA at Day 57 (Cohort 1) and Day 140 (Cohort 2).

    Safety
    • Percentage of subjects with solicited local AEs of injection site pain, erythema, induration, and swelling on the day of vaccination and then daily through Day 7 after each vaccination (including the day of vaccination).
    • Percentage of subjects with solicited systemic AEs of headache, fatigue, myalgia, arthralgia, vomiting (number per day/intensity), and diarrhea (number per day/consistency) for children aged 4 to <9 years; and irritability/fussiness, drowsiness, loss of appetite, vomiting (number per day/intensity), and diarrhea (number per day/consistency) for children aged 6 weeks to <4 years on the day of vaccination and daily through Day 7 after each vaccination.
    • Body temperature on the day of vaccination (approximately 30 minutes and 6 hours later); then daily through Day 7 after each vaccination.
    • Percentage of subjects with unsolicited AEs for 28 days after each vaccination.
    • Percentage of subjects with SAEs throughout the trial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint of evalution occuring at different points for each Primary endpoint, all stated in E.5.1 of this form.
    E.5.2Secondary end point(s)
    Immunogenicity
    Pan-Ig ELISA
    • Seroresponse rate in serum anti-NoV GI.1 VLP antibody titers as measured by Pan-Ig ELISA on Day 57 (Cohort 1) and Day 140 (Cohort 2).
    • Seroresponse rate in serum anti-NoV GII.4 VLP antibody titers as measured by Pan-Ig ELISA on Day 57 (Cohort 1) and Day 140 (Cohort 2).
    • GMT of anti-NoV GI.1 VLP antibody titers as measured by Pan-Ig ELISA on Day 57
    (Cohort 1) and Day 140 (Cohort 2).
    • GMT of anti-NoV GII.4 VLP antibody titers as measured by Pan-Ig ELISA on Day 57
    (Cohort 1) and Day 140 (Cohort 2).
    • GMFR of anti-NoV GI.1 VLP antibody titers as measured by Pan-Ig ELISA on Day 57
    (Cohort 1) and Day 140 (Cohort 2).
    • GMFR of anti-NoV GII.4 VLP antibody titers as measured by Pan-Ig ELISA on Day 57
    (Cohort 1) and Day 140 (Cohort 2).

    HBGA Binding Assay
    • Seroresponse rate in serum anti-NoV GI.1 VLP and GII.4 VLP antibody titers as measured by HBGA binding assay on Day 57 (Cohort 1) and Day 140 (Cohort 2).
    • Seroresponse rate in serum anti-NoV GI.1 VLP antibody titers as measured by HBGA binding assay on Day 57 (Cohort 1) and Day 140 (Cohort 2).
    • Seroresponse rate in serum anti-NoV GII.4 VLP antibody titers as measured by HBGA
    binding assay on Day 57 (Cohort 1) and Day 140 (Cohort 2).
    • BT50 of anti-NoV GI.1 VLP antibody titers as measured by HBGA binding assay on Day 57 (Cohort 1) and Day 140 (Cohort 2).
    • BT50 of anti-NoV GII.4 VLP antibody titers as measured by HBGA binding assay on Day 57 (Cohort 1) and Day 140 (Cohort 2).
    • GMFR of anti-NoV GI.1 VLP antibody titers as measured by HBGA binding assay on Day 57 (Cohort 1) and Day 140 (Cohort 2).
    • GMFR of anti-NoV GII.4 VLP antibody titers as measured by HBGA binding assay on Day 57 (Cohort 1) and Day 140 (Cohort 2).

    Safety
    • Percentage of subjects with any AE leading to subject’s withdrawal from the trial - from the day of vaccination through Day 210 (Cohort 1) and Day 293 (Cohort 2).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint of evalution occuring at different points for each Secondary endpoint, all stated in E.5.2 of this form.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Colombia
    Panama
    E.8.7Trial has a data monitoring committee Yes
    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.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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: 840
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 540
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 300
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children between the ages of 6 weeks and 9 years.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 840
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Colombia
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