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    Summary
    EudraCT Number:2015-001541-92
    Sponsor's Protocol Code Number:444563/028/029/030,107070,72,76
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-06-11
    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 number2015-001541-92
    A.3Full title of the trial
    A phase III, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine 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 and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants.
    A.3.2Name or abbreviated title of the trial where available
    Rota-028/029/030,Rota-028/029/030EXT:Y3
    A.4.1Sponsor's protocol code number444563/028/029/030,107070,72,76
    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 typeequal
    D.3.10.3Concentration number6.5
    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
    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 (Active immunisation of infants against gastroenteritis (GE) due to rotavirus (RV).)
    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
    •In all subjects, to determine if two doses of GSK Biologicals’ HRV vaccine given concomitantly with routine vaccinations* can prevent severe rotavirus gastroenteritis (RV GE) caused by the circulating wild-type RV strains during the period starting from 2 weeks after Dose 2 until 2 years of age. (*Whenever Oral Polio Vaccination (OPV) is used a minimum 2-week interval should be observed between HRV vaccine and OPV doses.)
    •In all subjects, to assess the safety of HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.
    E.2.2Secondary objectives of the trial
    HRV vac. efficacy and if 2 doses can prevent severe RV GE caused by the wild type G1, non-G1, & each non-G1 types, and severe GE, from 2 weeks after dose 2 up to 2 years and 3 years of age
    If 2 doses of HRV vac. can prevent RV GE caused by the circulating wild-type RV strains & requiring hospitalization & re-hydration therapy in a medical facility, up to 2 & 3 years of age
    If 2 doses of HRV vac. can prevent RV GE caused by the circulating wild-type RV strains during the period starting from 2 weeks after Dose 2 until one year of age
    safety of HRV vac. in terms of occurrence of serious adverse events (SAEs) from Dose 1 until Visit 5 & in terms of occ. of related SAEs until study end
    Safety of HRV vac. in terms of occ. of definite IS during the period starting from Dose 1 until 2 years
    Mortality up to the age of 2 years
    In a subset of 100 subjects per country, to assess the immunogenicity of HRV vac. in terms of RV IgA antibody titres 1 or 2 months after 2nd study vac. dose
    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, will stay/live in the study area) should be en-rolled in the study.
    •A male or female between, and including, 6 and 12 weeks (42-90 days) of age in Hong Kong and Taiwan or 11 to 17 weeks (77-125 days) of age in Singapore at the time of the first vaccination according to the country recommendations for the routine vaccination schedules.
    •Written informed consent obtained from the parent or guardian of the subject, prior any study procedure.
    •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
    E.4Principal exclusion criteria
    •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days pre-ceding the first dose of study vaccine or placebo, or planned use during the study period.
    •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
    •Child is unlikely to remain in the study area for the duration of the study
    •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
    •History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
    •Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Oral intake of immunoglobulins via e.g. breastfeeding is allowed.
    •Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
    •First or second degree of consanguinity of parents.
    E.5 End points
    E.5.1Primary end point(s)
    1.Occurrence of severe RV GE* caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until two years of age. * Severe GE is defined as a gas-troenteritis episode requiring hospitalization and/or re-hydration therapy (equivalent to WHO plan B or C) in a medical facility with a score of 11 or greater on the Vesikari scale.
    2.Occurrence of definite IS cases.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Occurrence of GE: During the period starting from 2 weeks after Dose 2 until two years of age
    IS: Within 31 days after each vaccination (Day 0 –Day 30)
    E.5.2Secondary end point(s)
    Occurrence of severe RV GE caused by the wild RV strain of serotype G1.
    Occurrence of severe RV GE due to non-G1 serotypes
    Occurrence of severe RV GE due to each non-G1 serotype
    Occurrence of severe RV GE caused by the circulating wild-type RV strains, of severe RV GE caused by the wild RV strain of serotype G1, of severe RV GE due to non-G1 serotypes and of severe RV GE due to each non-G1 serotype
    Occurrence of RV GE caused by the circulating wild-type RV strains and requiring hospitalization and/or rehydration therapy (equivalent to WHO plan B or C) in a medical facility
    Occurrence of severe RV GE caused by the circulating wild-type RV strains
    For the LTFU: Occurrence of severe RV GE caused by the wild RV strains.
    For the LTFU: Occurrence of severe RV GE caused by the wild RV strain of serotype G1
    For the LTFU: Occurrence of severe RV GE due to non-G1 serotypes
    For the LTFU: Occurrence of severe RV GE due to each non-G1 serotype
    For the LTFU: Occurrence of RV GE caused by the circulating wild-type RV strains and requiring hospitalization and/or rehydration therapy (equivalent to WHO plan B or C) in a medical facility
    For the LTFU: Occurrence of severe RV GE caused by the circulating wild-type RV strains.
    For the LTFU: Occurrence of severe GE
    For all subjects, occurrence of SAEs
    For all subjects, occurrence of definite IS
    For all subjects, occurrence of mortality
    Serum rotavirus IgA antibody titres in all subjects at visits 1 and 3 in a subset of 100 subjects per country.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Severe RV GE: During the period starting from 2 weeks after Dose 2 until two years of age,
    Severe RV GE caused by the circulating wild-type RV strains: from Dose 1, From one year of age up to two years of age, During the period starting from 2 weeks after Dose 2 until one year of age
    Severe RVGE requiring hospitalization: During the period starting from 2 weeks after Dose 2 until two years of age.
    For the LTFU: During the period starting from 2 weeks after Dose 2 until three years of age
    SAEs: From Dose 1 until Visit 5 and occurrence of related SAEs from Visit 5 until study end.
    IS: During the period starting from Dose 1 until two years of age
    Mortality: Up to the age of 2 years
    Immunogenicity: At Visits 1 and 3
    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
    Hong Kong
    Singapore
    Taiwan
    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 years3
    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: 10708
    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: 10708
    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 10708
    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: Singapore
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