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    Summary
    EudraCT Number:2015-001485-26
    Sponsor's Protocol Code Number:102248,111274
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-06-22
    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 number2015-001485-26
    A.3Full title of the trial
    A phase III, double-blind, randomised, placebo-controlled, multi-center study to assess the efficacy, safety and immunogenicity of two or three doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine given concomitantly with routine EPI vaccinations in healthy infants.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy, safety and immunogenicity of two or three doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine given concomitantly with routine EPI vaccinations in healthy infants.
    A.3.2Name or abbreviated title of the trial where available
    Rota-037, Rota-037 EXT:Y2
    A.4.1Sponsor's protocol code number102248,111274
    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 SponsorGlaxoSmithKline Biologicals
    B.1.3.4CountryBelgium
    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 supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de l'Institut, 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number442089904466
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 Rotarix
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals S.A,.
    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.3.4Pharmaceutical form Powder and solvent for oral suspension
    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 INN-
    D.3.9.3Other descriptive nameHUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED)
    D.3.9.4EV Substance CodeSUB22357
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number6.0
    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 placeboPowder and solvent for oral suspension
    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
    Healthy volunteers
    E.1.1.1Medical condition in easily understood language
    Rotavirus gastroenteritis
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if the GSK Biologicals' HRV vaccine (pooled HRV groups) given concomitantly with routine EPI vaccinations can prevent severe RV GE (>11 on the 20-point Vesikari scoring system) caused by the circulating wild-type RV strains during the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 6.
    Criteria: The primary objective will be reached if the lower limit of the 95% CI on vaccine efficacy is >0%.
    E.2.2Secondary objectives of the trial
    •To assess efficacy of HRV vaccine given concomitantly with routine EPI vaccinations in terms of
    -hospitalisation and/or supervised re-hydration therapy in a medical facility for RV GE caused by circulating wild-type RV strains
    -severe RV GE caused by circulating wild-type RV strains after 3 doses vs 2 doses
    -severe RV GE (>11 on the 20-point Vesikari scoring system) caused by circulating wild-type RV strains, wild type G1, non-G1 & severe RVGE in for the South African subset of subjects who were fully vaccinated before start of the RV season
    -Any RV GE caused by circulating wild-type RV strains
    •To assess safety of 2 or 3 doses of HRV vaccine compared with placebo in terms of AEs leading to drop-out and SAEs
    •To assess immunogenicity of HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion, seropositivity rate & serum antibody concentrations
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
    •A male or female child between, and including, 5 and 10 weeks of age at the time of the first study vaccination.
    •Written informed consent obtained from the parent or guardian of the subject who is of legal age (i.e. parent/guardian should be 18 years or older). (South Africa-specific Amendment 5: 10 July 2006)
    •Healthy subjects as established by medical history and clinical examination before entering into the study.
    •In South Africa, birth weight > 2000 g or if weight un-known, gestation period > 36 weeks.
    E.4Principal exclusion criteria
    •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
    •Planned administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccine(s) and ending 14 days after.
    •Chronic administration (defined as more than 14 days) of immunosuppressants since birth. (Topical steroids are al-lowed.)
    •History of use of experimental rotavirus vaccine.
    •Previous routine vaccination except BCG, HBV and OPV vaccination at birth (should be documented in the CRF). (Amendment 1: 24 August 2005)
    •Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.
    •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
    •History of allergic disease or reaction likely to be exacer-bated by any component of the vaccine.
    •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F).) (warrants deferral of vaccination).
    •Gastroenteritis within 7 days preceding the first study vaccine administration (warrants deferral of the vaccina-tion).
    •Previous cofirmed occurrence of RV GE.
    •A family history of congenital or hereditary immunodefi-ciency.
    •Administration of immunoglobulins and/or blood products since birth or planned administration during the study pe-riod.
    •History of any neurologic disorders or seizures.
    •Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of severe RV GE (score > 11 on a 20-point Vesikari scoring system caused by the circulating wild-type RV strains in pooled HRV groups versus the placebo group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 6.
    E.5.2Secondary end point(s)
    Occurrence of hospitalisation and/or supervised re-hydration therapy (equivalent to WHO plan B or C) in a medical facility for RV GE caused by the circulating wild-type RV strains.
    Occurrence of severe RV GE caused by the circulating wild-type RV strains of G1 serotype.
    Occurrence of severe RV GE caused by the circulating wild-type RV strains of non-G1 serotype.
    Occurrence of any and severe RV GE caused by the circulating wild-type RV strains.
    Occurrence of severe GE.
    Occurrence of severe RV GE caused by the circulating wild-type RV strains.
    In South Africa, occurrence of severe RV GE caused by the circulating wild-type RV strains for the subset of subjects who were fully vaccinated before the beginning of the RV season

    For subjects in Cohort 2 South Africa and the cohort in Malawi:
    Occurrence of severe RV GE (score >= 11 on a 20-point Vesikari scoring system caused by the circulating wild-type RV strains
    Occurrence of hospitalisation and/or supervised re-hydration therapy (equivalent to WHO plan B or C) in a medical facility for RV GE caused by the circulating wild-type RV strains
    Occurrence of severe RV GE caused by the circulating wild-type RV strains of G1 serotype.
    Occurrence of severe RV GE caused by the circulating wild-type RV strains of non-G1 serotype
    For all subjects, occurrence of AEs/SAEs leading to drop-out
    In a subset of subjects, seroconversion rate and Geometric Mean concentration (GMC) to anti-rotavirus IgA antibody
    In all subjects, seropositivity rate and GMC to anti-rotavirus IgA antibody
    E.5.2.1Timepoint(s) of evaluation of this end point
    RV GE and Hospitalisation: During the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 6.
    Severe RV GE: During the period starting from Dose 1 of the study vaccine until Visit 6.
    South Africa: During the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 6
    Cohort 2: During the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 7, and from Visit 6 to Visit 7
    G1 serotype: During the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 7, and from Visit 6 to Visit 7
    Non-G1 serotype: During the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 7, and from Visit 6 to Visit 7
    AEs/SAEs: Throughout the entire study period
    Immunogenicity: At Visit 4
    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) 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 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
    Malawi
    South Africa
    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 years2
    E.8.9.2In all countries concerned by the trial months0
    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: 4941
    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: 4941
    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 4941
    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: South Africa
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