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    Summary
    EudraCT Number:2015-001540-10
    Sponsor's Protocol Code Number:444563/024
    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 number2015-001540-10
    A.3Full title of the trial
    A phase III, double-blind, randomised, placebo-controlled, multi-country and multi-center study to assess the efficacy, immunogenicity and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine given concomitantly with routine expanded program on immunisation (EPI) vaccinations including oral poliovirus vaccine (OPV) in healthy infants.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III study to assess the efficacy, immunogenicity and safety of GSK Biologicals’ human rotavirus (HRV) vaccine given concomitantly with routine expanded program on immunisation (EPI) vaccinations including oral poliovirus vaccine (OPV) in healthy infants across 6 countries in Latin America.
    A.3.2Name or abbreviated title of the trial where available
    Rota-024
    A.4.1Sponsor's protocol code number444563/024
    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 I'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 Bilogicals 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
    Rotavirus gastroenteritis
    E.1.1.1Medical condition in easily understood language
    Rotavirus infection
    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 two doses of GSK Biologicals’ HRV vaccine given concomitantly with routine EPI vaccinations including OPV can prevent severe 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.
    E.2.2Secondary objectives of the trial
    To assess if severe RVGE can be prevented by HRV vaccine, caused by wild RV strain serotype G1, non-G1 serotypes and due to each non-G1 during the period starting from 2 weeks after Dose 2 until 1 year of age.
    To assess severe RVGE can be prevented by HRV vaccine after 1st dose.
    To assess safety (SAEs) throughout the study period.
    In a subset of 300 subjects, to explore the effect of HRV vaccine on immune response to concurrently administered routine EPI vaccinations and to assess immunogenicity of anti-RV IgA antibody concentrations 1 to 2 months after the 2nd dose.
    In a subset of 900 subjects, to demonstrate NI of HRV over placebo group in terms of immune response to concurrently administered OPV, 1 month after Dose 3 in a subset with no OPV given in neonatal period and to explore the effect of HRV vaccine on immune response, 1 month after Dose 1 and 2 of OPV in a subset with no OPV given in neonatal period and after Dose 1, 2 and 3 in a subset with OPV given in neonatal period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Subjects who the investigator believed that their parents/guardians could and would comply with the requirements of the protocol
    -A male or female between, and including, 6 and 12 weeks (42-90 days) of age 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 preceding 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.
    -Child was 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 pe-riod.
    -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.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of severe RV GE caused by the wild RV strains
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 weeks after Dose 2 until the infant turns one year of age
    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 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
    Safety endpoint
    Occurrence of SAEs
    Immunogenicity endpoints
    In a subset of 300 subjects:
    Serum rotavirus IgA antibody concentrations
    GMTs for anti-polio type 1, 2 and 3 antibodies.
    Seroprotection status:
    anti-poliovirus serotype 1, 2 and 3 antibody titre greater than or equal to 8
    One to two months after the third dose of routine EPI vaccinations (at Visit 4):
    Geometric mean antibody concentrations (GMC)/geometric mean antibody titres (GMT) for anti-PRP, anti-diphtheria and anti-tetanus, anti-BPT, anti- poliovirus serotypes 1, 2 and 3, and anti-HBsAg antibodies.
    Seroprotection status:
    anti-PRP antibody concentration greater than or equal to 0.15 and 1.0 mcg/ml
    anti-diphtheria toxoid antibody concentration greater than or equal to 0.1 IU/ml
    anti-tetanus toxoid antibody concentration greater than or equal to 0.1 IU/ml
    anti-HBsAg antibody concentration greater than or equal to 10.0 mIU/ml
    anti-poliovirus serotype 1, 2 and 3 antibody titre greater than or equal to 8
    Seropositivity status:
    anti-BPT antibody concentrations greater than or equal to 15 EL.U/ml
    In a subset of 900 subjects:
    GMTs for anti-polio type 1, 2 and 3 antibodies
    Seroprotection status:
    anti-poliovirus serotype 1, 2 and 3 antibody titre greater than or equal to 8
    E.5.2.1Timepoint(s) of evaluation of this end point
    RV GE caused by wild RV strain of serotype G1, non-G1 and each non-G1 and circulating wild RV strains, serotype G1, non-G1 and each non-G1 serotype: 2 weeks after Dose 2 until the infant turns 1 year of age and from Day 0 until the infant turns 1 year of age respectively.
    SAEs:Day 0-infant turns 1 year of age
    Subset of 300:RV IgA antibody, GMTs and seroprotection for anti-poliotypes 1,2 and 3:1 to 2 months after the 2nd dose (Visit 3). GMC/T and seroprotection status for anti-PRP, D, T, poliovirus types 1, 2 and 3, and HBsAg. GMC/T and seropositivity status for anti-BPT: 1 to 2 months after the 3rd dose of routine EPI vaccinations (Visit 4)
    Subset of 900: GMT and seroprotection status for anti-polio type 1, 2 and 3:1 month after each dose of routine EPI vaccinations (Visits 2, 4 and 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 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
    Argentina
    Brazil
    Colombia
    Dominican Republic
    Honduras
    Panama
    E.8.7Trial has a data monitoring committee Yes
    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 months3
    E.8.9.2In all countries concerned by the trial days17
    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: 6568
    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: 6568
    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 6568
    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: Brazil
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