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    Summary
    EudraCT Number:2017-000451-14
    Sponsor's Protocol Code Number:112896
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-06-01
    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 number2017-000451-14
    A.3Full title of the trial
    An open, single group, multi-centric, post marketing surveillance (PMS) to monitor the reactogenicity and safety of oral live attenuated human rotavirus (HRV) vaccine, Rotarix when administered according to the Prescribing Information (PI) to Indian infants.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals’ Rotarix (Human Rotavirus Vaccine) in Indian infants
    A.3.2Name or abbreviated title of the trial where available
    ROTA-071 PMS
    A.4.1Sponsor's protocol code number112896
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00938327
    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
    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 from the age of 6 weeks for prevention of gastroenteritis due to rotavirus infection).
    E.1.1.1Medical condition in easily understood language
    Diarrhoea.
    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 assess the reactogenicity of Rotarix in terms of occurrence of at least one grade “2” or grade “3” fever, vomiting or diarrhoea within the 8-day (Day 0 - Day 7) follow-up period after any Rotarix vaccination.
    E.2.2Secondary objectives of the trial
    • To assess the reactogenicity of Rotarix in terms of occurrence of solicited adverse events (AEs) within a 8-day (Day 0 – Day 7) follow-up period after each dose of the vaccination.
    • To assess the safety of Rotarix in terms of occurrence of unsolicited AEs within a 31-day (Day 0 – Day 30) follow-up period after any vaccination, according to Medical Dictionary for Regulatory Activities (MedDRA) classification.
    • To assess the safety of Rotarix in terms of serious adverse events (SAEs) throughout the surveillance period after the first dose administered in the PMS.
    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 should be enrolled in this PMS.
    • A male or female infant, from the age of 6 weeks at the time of the first vaccination and less than 24 weeks of age at the time of second vaccination.
    • Written informed consent obtained from the parent or guardian of the subject.
    E.4Principal exclusion criteria
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    • Concurrently participating in another clinical study, at any time during the surveillance period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
    • Acute disease at the time of enrolment.
    • Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose the subject for intussusception (IS).
    • Known hypersensitivity after previous administration of rotavirus vaccine or to any component of the vaccine.
    •Gastroenteritis within 7 days preceding vaccination.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of at least one grade “2” or grade “3” fever, vomiting or diarrhoea.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the 8 day (Day 0-Day 7) follow-up period after any Rotarix vaccination.
    E.5.2Secondary end point(s)
    1) For each type of solicited symptom, occurrence of the symptom.
    2) Occurrence of unsolicited symptoms according to MedDRA classification.
    3) Occurrence of Serious adverse events (SAEs).
    E.5.2.1Timepoint(s) of evaluation of this end point
    For endpoint 1: Within the 8-day (Day 0 - Day 7) follow-up period after each dose of the vaccination.
    For endpoint 2: During the 31-day (Day 0 - Day 30) follow-up period after any vaccination.
    For endpoint 3: Throughout the surveillance period following the first dose administered in the study.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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
    India
    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 years0
    E.8.9.2In all countries concerned by the trial months3
    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: 328
    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: 328
    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 371
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: India
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