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    Summary
    EudraCT Number:2017-000277-37
    Sponsor's Protocol Code Number:V260-060
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-03-10
    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 number2017-000277-37
    A.3Full title of the trial
    Post-marketing, Randomized, Open-label Study to Assess the Immunogenicity and Safety of Concomitant Administration of V260 and Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Japanese Healthy Infants
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to review the Immunogenicity and Safety of RotaTeq™ (pentavalent rotavirus vaccine) given with Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Japanese Healthy Infants
    A.3.2Name or abbreviated title of the trial where available
    Immunogenicity and safety assessment of V260 and DTP-IPV in Japanese healthy infants
    A.4.1Sponsor's protocol code numberV260-060
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01926015
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & 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.IMP: 2
    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 Tetrabik®
    D.2.1.1.2Name of the Marketing Authorisation holderBIKEN
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameAdsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDIPHTHERIA, TETANUS, PERTUSSIS AND POLIOMYELITIS (INACTIVATED) VACCINE (ADSORBED)
    D.3.9.3Other descriptive nameDIPHTHERIA, TETANUS, PERTUSSIS AND POLIOMYELITIS (INACTIVATED) VACCINE (ADSORBED)
    D.3.9.4EV Substance CodeSUB25285
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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
    To demonstrate that the immunogenicity of DTP-IPV in the concomitant administration group (Group 1) is non-inferior to that in the staggered administration group (Group 2).
    E.2.2Secondary objectives of the trial
    (1) To evaluate the safety and general tolerability of the concomitant administration of DTP-IPV and V260.
    (2) To summarize the GMTs (Geometric mean titers) of DTP-IPV descriptively for each antibody in Japanese infants both for the concomitant administration group (Group 1) and the staggered administration group (Group 2).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (buccal swabs) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    E.3Principal inclusion criteria
    1. Healthy Japanese infants.
    2. Age 6 weeks through less than 11 weeks (≥42 days to ≤76 days from Date of Birth) at Visit 1.
    3. Parent/legal guardian understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent. The parent/guardian may also provide consent for Future Biomedical Research. However, the patient may participate in the main trial without participating in the Future Biomedical Research.
    E.4Principal exclusion criteria
    At Visit 1, subjects should not have any exclusion criteria. As for exclusion criteria with an asterisk [*], if the subject meets this criterion at any visit, the visit may be resche duled when the criterion no longer applies.
    1. * Subjects who are clearly feverish, axillary temperature ≥37.5ºC at the time of vaccination.
    2. * Subjects who clearly have acute active disease.
    3. Subjects with a history or a risk of hypersensitivity and/or anaphylaxis to any of the product ingredients in V260 and/or DTP-IPV.
    4. Subjects with gastrointestinal disorder (active gastrointestinal disease, chronic diarrhea, prior rotavirus gastroenteritis, abdominal surgery), growth retardation, or failure to thrive.
    5. Subject with history of intussusception.
    6. Subject with untreated congenital gastrointestinal disorder (such as Meckel diverticulum) that may increase the onset of intussusceptions.
    7. Known or suspected impairment of immunological function, including severe combined immunodeficiency (SCID).
    8. Subjects who have underlying diseases such as cardiovascular, renal, liver, or blood diseases.
    9. Subjects with a history of convulsion.
    10. Subjects undergoing immunosuppressive therapy (including high -dose systemic corticosteroids [≧2mg/kg/day of prednisolone or equivalent] ) or subjects living with a close relative with congenital immune deficiency. Note: Subject using nonsystemic corticosteroids (e.g., topical, ophthalmic, or inhaled) will be eligible for vaccination.
    11. Subjects who have received a blood transfusion or blood products, including immunoglobulin.
    12. Prior vaccination of rotavirus vaccine and/or DTP-IPV vaccine (including any component of DTP-IPV vaccine).
    13. Subjects who have not passed 28 days after live vaccine administration or 7 days after receiving inactivated vaccine.
    14. Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study.
    15. Subjects who plan to permanently relocate from the area prior to the completion of the study or to leave for an extended period (visiting grandmother’s home) of time when study visits would be scheduled.
    16. Subjects who are at high risk of tuberculosis exposure (e.g., subjects living in a household with a person who is under TB treatment or a person with suspected infection with the tubercle bacillus).
    17. * Inability to obtain blood specimen at randomization visit. Note: Re-schedule visit so that baseline specimen may be obtained prior to the first vaccination
    18. Subjects whom the physician considers unsuitable to vaccinate.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity Endpoints
    The endpoint is the percentage of subjects who achieve a serologic response as defined in the protocol for diphtheria toxin, tetanus toxin, pertussis toxin, pertussis FHA and Polio virus type 1/2/3 at 4-6 weeks after the 3rd dose of DTP-IPV elicited by vaccination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4-6 weeks after the 3rd dose of DTP-IPV
    E.5.2Secondary end point(s)
    Immunogenicity Endpoints
    The secondary immunogenicity endpoints for evaluating antibody responses to DTP-IPV are geometric mean titers (GMTs) of immunogenicity measurements (antibody levels) baseline (pre-vaccination) and at 4-6 weeks after the 3rd dose.

    Safety Endpoints
    For the evaluation of safety of V260 when administered concomitantly with DTP-IPV, all subjects in the study will be followed for any clinical adverse experiences occurring within 14 days of all study visits. In addition, vaccine-related serious adverse experiences, deaths, and cases of intussusception (ECI) are to be reported at any time during the study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity Endpoints
    Baseline and at 4-6 weeks after the 3rd dose.

    Safety Endpoints
    14 days following any scheduled visit (visits 1-6)
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.2.3.1Comparator description
    Experimental (Staggered group)
    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 months9
    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: 192
    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: 192
    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 192
    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 Japan Development
    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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