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    Summary
    EudraCT Number:2017-000264-15
    Sponsor's Protocol Code Number:V260-029
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-03-07
    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 number2017-000264-15
    A.3Full title of the trial
    A phase III randomized, placebo-controlled clinical trial to study the efficacy and safety of V260 in healthy infants in Japan
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of RotaTeq™ in Healthy Japanese Infants
    A.4.1Sponsor's protocol code numberV260-029
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00718237
    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 SponsorBanyu Pharmaceutical Co., Ltd. a subsidiary of Merck & Co.,Inc, Kenilworth, New Jersey, USA
    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 supportBanyu Pharmaceutical Co., Ltd. a subsidiary of Merck & Co.,Inc, Kenilworth, New Jersey
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck & Co.,Inc,
    B.5.2Functional name of contact pointSusan Kaplan
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive - P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1267-305-1633
    B.5.5Fax number+1267-305-6505
    B.5.6E-mailsusan.kaplan@merck.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 Yes
    D.2.1.1.1Trade name RotaTeq™
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRotavirus Vaccine, Live, Oral, Pentavalent
    D.3.2Product code V260
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT
    D.3.9.2Current sponsor codeV260
    D.3.9.3Other descriptive nameLive Pentavalent (G1, G2, G3, G4, P1A[8]) Human-Bovine Rotavirus Reassortant Vaccine
    D.3.9.4EV Substance CodeSUB25745
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number11500000
    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 placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of Rotavirus Gastroenteritis Caused by Serotypes G1, G2, G3, G4, and G-Serotypes Associated With P1A [8] (e.g., G9) in Infants
    E.1.1.1Medical condition in easily understood language
    Diarrhea and vomiting caused by the rotavirus germ in infants.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10039232
    E.1.2Term Rotavirus gastroenteritis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    (1) To evaluate the efficacy of a 3-dose regimen of V260 against rotavirus gastroenteritis of any severity caused by rotavirus serotypes G1, G2, G3, G4 and Gserotypes associated with serotype P1A (including G9) occurring at least 14 days following the third dose in healthy Japanese infants.
    (2) To assess the safety of V260 with respect to all adverse experiences occurring within 14 days of any dosing in healthy Japanese infants.
    E.2.2Secondary objectives of the trial
    (1) To evaluate the efficacy of a 3-dose regimen of V260 against moderate to severe and severe rotavirus gastroenteritis caused by rotavirus serotypes G1, G2, G3, G4 and those associated with serotype P1A occurring at least 14 days following the third dose.
    (2) To evaluate the efficacy of a 3-dose regimen of V260 against rotavirus gastroenteritis (moderate-severe, severe, and any severity, respectively) caused by any rotavirus serotype occurring at least 14 days following the third dose.
    (3) To evaluate the cumulative efficacy following the first dose of a 3-dose regimen of V260 against rotavirus gastroenteritis (moderate-severe, severe, and any severity, respectively) caused by i) rotavirus serotypes G1, G2, G3, G4 and those associated with serotype P1A, and by ii) any rotavirus serotype.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy Japanese infants
    2. Age 6 through exactly 12 weeks (≥42 days to ≤84 days from Date of Birth) upon the day of receipt of the first study vaccination (Day 1)
    3. Parent/legal guardian understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
    E.4Principal exclusion criteria
    1. History of congenital abdominal disorders, intussusception, or abdominal surgery.
    2. Known or suspected impairment of immunological function.
    3. Known hypersensitivity to any component of the rotavirus vaccine, e.g., purified sucrose, sodium citrate, sodium phosphate, sodium hydroxide, surface active agent (Polysorbate 80), and inorganic salts, amino acids and vitamins contained in the culture media for tissue culture used into the manufacturing process of a vaccine.
    4. Prior administration of any rotavirus vaccine.
    5. Fever, with a rectal temperature ≥38.1ºC or axillary temperature ≥37.5ºC at the time of vaccination.
    6. History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive.
    7. Clinical evidence of active gastrointestinal illness. (Note that infants with gastroesophageal reflux disease [GERD] may participate in the study as long as the GERD is well controlled with or without medication.)
    8. Receipt of intramuscular, oral, or intravenous corticosteroid treatment (Note that infants on inhaled steroids may participate in the study.)
    9. Infants residing in a household with an immunocompromised person, including individuals with congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or with those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids.
    10.Any prior receipt of a blood transfusion or blood products, including immunoglobulins.
    11. Any infant who cannot be adequately followed for safety by telephone, e-mail or clinic visit.
    12. Receipt of oral poliovirus vaccine (OPV) or Bacille Calmette-Guérin (BCG) within 27 days prior to the first dose of study vaccine/placebo
    13. Subjects who are concurrently participating in or are anticipated to participate in other studies of investigational products at any time during the study period. Subjects enrolled in observational studies may be included; these will be reviewed on a caseby-case basis for approval by the SPONSOR.
    14. Any condition, which, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the incidence rate of rotavirus gastroenteritis caused by the rotavirus serotype G1, G2, G3, G4 and those associated with P1A occurring at least 14 days after third dose.
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days post dose 3
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints include the incidence rate of rotavirus gastroenteritis by disease severity and caused by all rotavirus serotypes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The presence or absence of rotavirus gastroenteritis is evaluated from the first vaccination to the end of the study.
    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 Yes
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 trial2
    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 Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Japan
    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.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial days4
    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: 762
    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: 762
    F.1.1.5Children (2-11years) No
    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 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 762
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Omagari Children's Clinic and others (multicenter trial)
    G.4.3.4Network Country Japan
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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