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    Summary
    EudraCT Number:2015-001542-29
    Sponsor's Protocol Code Number:106260
    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 number2015-001542-29
    A.3Full title of the trial
    A phase IIIb, randomized, double-blind, placebo-controlled study to explore the existence of horizontal transmission of the RIX4414 vaccine strain between twins within a family.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunization of infants 6-14 weeks of age, with GlaxoSmithKline Biologicals’ Rotavirus vaccine to explore the existence of transmission of rotavirus vaccine strain between twins in a family.
    A.3.2Name or abbreviated title of the trial where available
    Rota-052
    A.4.1Sponsor's protocol code number106260
    A.5.4Other Identifiers
    Name:US NIH Grant NumberNumber:BB-IND #9231
    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 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 number6.0
    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
    Rotavirus (RV) 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
    Estimate the rate of transmission of the HRV vaccine strain to twin receiving placebo using RV detection by ELISA and vaccine strain identification using appropriate molecular technique.
    E.2.2Secondary objectives of the trial
    -To identify potential genetic variation (full genome sequencing) of any HRV vaccine strain isolated from twin receiving placebo and from the twin receiving the HRV vaccine if applicable.
    In case of transmission, to determine the infectious viral load in the stool of the twin receiving placebo.
    -To determine the rate of seroconversion and GMCs to anti-RV IgA antibodies at Visit 3 in twins vaccinated with HRV vaccine and in twins receiving the placebo (seroconversion caused either by natural infection or by transmission).
    -To assess the occurrence of gastroenteritis (GE) until study end and RV GE until Visit 3.
    -To assess the safety of the study vaccine throughout the study period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects with a live twin living in the same household who is also enrolled in this study.
    Subjects born after a gestation period of ≥ 32 weeks.
    Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (stool collection, return for follow-up visits, etc.) were to be enrolled in the study.
    A male or female between, and including, 6 and 14 weeks of age at the time of the first study vaccination.
    Written informed consent obtained from the parent or guardian of the subjects.
    Healthy subjects as established by medical history and clinical examination before entering into the study.
    Discharged from hospital neonatal care stay.
    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.
    Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
    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.
    History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    Acute disease at time of enrolment. (Acute disease was defined as the presence of moderate or severe illness with or without fever i.e. temperature > 37.5°C as measured by an axillary thermometer or > 38.0°C as measured by a rectal thermometer).
    Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
    Contact with an immunosuppressed individual.
    Concurrently participating in another clinical study, at any time during the study period, in which the subject had been or was exposed to an investigational or a non-investigational product (pharmaceutical product or device).
    Chronic administration (defined as more than 14 days) of immunosuppressants since birth (topical steroids were allowed).
    Gastroenteritis within 7 days preceding the first study vaccine administration (warrants deferral of the vaccination).
    Documented HIV-positive subject.
    E.5 End points
    E.5.1Primary end point(s)
    Presence of HRV vaccine strain in any stool sample from twin receiving placebo as detected by ELISA and identified by using appropriate molecular technique.
    E.5.1.1Timepoint(s) of evaluation of this end point
    On the day of each dose of HRV vaccine or placebo or day before, then three times weekly for 6 consecutive weeks starting after each dose of HRV vaccine or placebo and on the day of Visit 3 (Week 13).
    E.5.2Secondary end point(s)
    Duration of HRV shedding per study group.
    Analysis by sequencing of genomic mutations in the HRV vaccine strain after transmission.
    Live viral vaccine load in the stool of the twin receiving placebo in case of transmission.
    Anti-rotavirus IgA antibody seroconversion and concentration in each group at Visit 3.
    Occurrence of GE
    Occurrence of AEs in all subjects
    Occurrence of SAEs in all subjects
    E.5.2.1Timepoint(s) of evaluation of this end point
    HRV shedding, sequencing of genetic mutations in HRV vaccine strain, viral vaccine load:On the day of each dose of HRV vaccine or placebo or day before, then three times weekly for 6 consecutive weeks starting after each dose of HRV vaccine or placebo and on the day of Visit 3 (Week 13).
    Anti-RV IgA antibody seroconversion: At Visit 3 (Week 13), Occurance of GE and RV GE: Day 0 till Visit 3 (Week 13)
    AEs: Within 31 days after each dose (Day 0-Day 30), SAEs: Day 0 to Week 17
    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 No
    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? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    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
    Dominican Republic
    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 years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days20
    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: 200
    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: 200
    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 200
    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: Dominican Republic
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