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    Summary
    EudraCT Number:2017-000263-32
    Sponsor's Protocol Code Number:V260-028
    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 number2017-000263-32
    A.3Full title of the trial
    A Double-Blind, Randomized, Placebo-Controlled, Safety and Tolerability Study of Live Pentavalent Human-Bovine Rotavirus
    Reassortant Vaccine in Chinese Healthy Adults, Children and Infants
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of RotaTeq™ (pentavalent rotavirus vaccine) in Chinese healthy adults, children and infants
    A.4.1Sponsor's protocol code numberV260-028
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00953056
    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 & 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 & 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 & 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) 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 children, and 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 V260 is generally well-tolerated in the Chinese healthy population, especially with respect to serious adverse experiences (SAEs) that occur within 14 days following vaccination.
    E.2.2Secondary objectives of the trial
    To summarize the fecal vaccine virus shedding rate in the targeted population (infants).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy adults ages 19 to 47 years for Cohort I.
    2. Healthy children ages 2 to 6 years for Cohort II.
    3. Healthy infants ages 6 to 12 weeks (≥42 to ≤84 days) for Cohort III.
    4. Subjects (or parents/legal guardians for subjects of Cohort II and Cohort III) who fully understand study procedures, alternative treatments available, the risks involved with the study, and voluntarily agree to participate by giving written informed consent.
    5. Subjects who are healthy based on the information collected on the medical history and physical examination.
    6. Negative urine -hCG test result for premenopausal female subjects of Cohort I.
    7. Premenopausal female subjects of Cohort I who have had sexual intercourse in the two weeks prior to enrollment must have been using effective contraception. Effective contraception will be considered to include oral birth control pills or at least single-barrier contraception (partner using condom or subject using diaphragm, contraceptive sponge, or intrauterine device (IUD), etc. Emergency contraception is not considered effective contraception for enrollment in the study).
    E.4Principal exclusion criteria
    1. Subjects in Cohort I and Cohort II receiving any vaccine within 14 days prior to enrollment or anticipated to receive any vaccine 14 days after the V260/placebo dose.
    2. Subjects in Cohort III, who anticipate receiving non-concomitant administration of any live vaccines (e.g., OPV) within 14 days prior to or after any V260/placebo dose. [Note: concomitant administration with dosing of V260/placebo on the same day as other usual childhood (EPI) vaccines, including OPV, is allowed and strongly encouraged.]
    3. History of known gastrointestinal diseases/bleeding, chronic diarrhea, congenital abdominal disorders, intussusception, abdominal surgery, irritable bowel syndrome (IBS), colitis, diverticulitis.
    4. Known or suspected impairment of immunological function.
    5. Known hypersensitivity to any component of the rotavirus vaccine, Individuals who develop symptoms suggestive of hypersensitivity after receiving a dose of study vaccine should not receive further doses, 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 in the manufacturing process of a vaccine.
    6. History of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty with breathing, hypotension, or shock) that required medical intervention.
    7. Prior administration of any rotavirus vaccines.
    8. Elevated temperature, with axillary temperature ≥37.1ºC for subjects of Cohort I, Cohort II, and Cohort III, within 24 hours prior to vaccination.
    9. Subjects participating in Group III only, history of known prior rotavirus disease, chronic diarrhea, or failure to thrive prior to vaccination.
    10. 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.)
    11. Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination. (Note that subjects on inhaled steroids may participate in the study.)
    12. 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.
    13. Subjects participating in Cohort III, any prior receipt of a blood transfusion or blood products, including immunoglobulins.
    14. Subjects who cannot be adequately followed for safety by telephone or home visit.
    15. Any condition, which, in the primary investigator’s opinion, may interfere with the evaluation of the study objectives.
    16. Female subjects participating in Cohort I, pregnancy or expecting to conceive during the study period. (Female subjects of child-bearing age and capacity must agree to use effective contraception for 3 months after administration of the study vaccine/placebo. Abstinence is considered an acceptable method of birth control).
    17. Subjects participating in Cohort I, history of drug or alcohol abuse.
    18. Subjects who plan to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled.
    19. 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.
    E.5 End points
    E.5.1Primary end point(s)
    Safety information regarding all adverse experiences with concentration on elevated temperature, vomiting, and diarrhea will be collected daily for 14 days (Day 1-14) following each dose of V260/placebo using Vaccination Report Card (VRC) starting with the date of vaccination
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 weeks (14 day period following any dose)
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety and Tolerability Study
    E.7.2Therapeutic exploratory (Phase II) No
    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 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
    China
    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 months6
    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: 96
    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: 48
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 48
    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: 48
    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 Yes
    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 144
    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 Center for Disease Control and Prevention, Nationality Autonomous Region
    G.4.3.4Network Country China
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: China
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