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    Summary
    EudraCT Number:2015-001543-36
    Sponsor's Protocol Code Number:107625
    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 number2015-001543-36
    A.3Full title of the trial
    A phase III, double-blind, randomised, placebo-controlled, multi-centre study in Japan to assess the efficacy, safety, reactogenicity and immunogenicity of the lyophilised formulation of GlaxoSmithKline (GSK) Biologicals’ live attenuated human rotavirus (HRV) vaccine, given as a two-dose primary vaccination course, in healthy infants previously uninfected with HRV.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate efficacy, safety, reactogenicity and immunogenicity study of the lyophilised formulation of human rotavirus (HRV) vaccine 444563 in healthy Japanese infants.

    A.3.2Name or abbreviated title of the trial where available
    Rota-056
    A.4.1Sponsor's protocol code number107625
    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.4.1Name of organisation providing supportGlaxoSmithKline Biologicals
    B.4.2CountryJapan
    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 two doses of the lyophilised formulation of GSK Biologicals’ HRV vaccine can prevent any RV GE leading to a medical intervention and caused by the circulating wild-type RV strains during the efficacy follow-up period
    E.2.2Secondary objectives of the trial
    •To assess the efficacy of two doses of the HRV vaccine against any & severe RV GE leading to a medical intervention & caused by the circulating wild-type RV strains, wild-type G1 & non-G1 serotypes during the efficacy follow-up period.
    •To assess efficacy of two doses of the HRV vaccine against hospitalisation due to RV GE caused by the circulating wild-type RV strains during the efficacy follow-up period.
    •To assess vaccine efficacy against any and severe RV GE leading to a medical intervention & caused by the circulating wild-type RV strains during the period starting from Dose 1 up to Visit 5.
    •To assess the safety and reactogenicity of two doses of HRV vaccine compared with placebo in terms of solicited symptoms, unsolicited adverse events (AEs) (31 days after each dose) and serious adverse events (SAEs) during the entire study.
    •To explore the immunogenicity of the HRV vaccine in terms of serum anti-rotavirus IgA antibody concentrations one month after the second 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) should be enrolled in the study.
    •A male or female infant between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vacci-nation.
    •Written informed consent obtained from the parent/guardian of the subject.
    •Healthy subjects as established by medical history and clinical examination before entering into the study.
    •Born between a gestation period of 36 and 42 weeks inclusive.
    E.4Principal exclusion criteria
    •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    •History of use of experimental rotavirus vaccine.
    •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
    •Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition determined by the investigator.
    •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
    •A family history of congenital or hereditary immunodeficiency.
    •Uncorrected congenital malformation (such as Meckel’s diverticulum) of the gastrointestinal tract that would pre-dispose for IS.
    •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. Axillary temperature <37.5°C.) Temperature greater than or equal to these cut-offs warrants deferral of the vacci-nation pending recovery of the subject.
    •Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
    •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
    •Previous confirmed occurrence of RV GE.
    •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).
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of any RV GE leading to medical intervention and caused by the circulating wild-type RV strains.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the efficacy follow-up period
    E.5.2Secondary end point(s)
    Occurrence of severe RV GE leading to a medical intervention and caused by the circulating wild-type RV strains
    Occurrence of any RV GE and severe RV GE leading to medical intervention and caused by the circulating wild-type RV strains of G1 serotype.
    Occurrence of any RV GE and severe RV GE leading to medical intervention and caused by the circulating wild-type RV strains of non-G1 serotypes
    Occurrence of hospitalisation due to RV GE caused by the circulating wild-type RV strains
    Occurrence of any RV GE and severe RV GE leading to medical intervention and caused by the circulating wild-type RV strains.
    Occurrence of each type of solicited symptom
    Occurrence of unsolicited adverse events according to Medical Dictionary for Regulatory Activities (MedDRA) classification
    Occurrence of serious adverse events
    Serum anti-rotavirus IgA antibody concentration
    Seroconversion in terms of anti-rotavirus IgA antibody
    E.5.2.1Timepoint(s) of evaluation of this end point
    Severe, G1 and non-G1 RV GE: During the efficacy follow-up period
    Wild-type RV GE: During the period starting from Dose 1 up to Visit 5
    Solicited symptoms: Within the 8-day solicited follow-up period (Day 0 to Day 7) after each dose of HRV vaccine/placebo
    Unsolicited symptoms: Within 31 days after any dose of HRV vaccine/Placebo (Day 0 to Day 30) after any dose of HRV vaccine/placebo
    SAEs: Throughout the study period
    Immunogenicity: At Visit 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 Yes
    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
    Japan
    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: 765
    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: 765
    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 765
    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: Japan
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