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    Summary
    EudraCT Number:2015-001484-39
    Sponsor's Protocol Code Number:444563/022
    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 number2015-001484-39
    A.3Full title of the trial
    A phase II, double-blind, randomized, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of three doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (RIX4414 at 10 Exp 6.5 CCID50) administered to human immunodeficiency virus (HIV) infected infants at 6, 10 and 14 weeks of age in South Africa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II study to assess the safety and immunogenicity of GlaxoSmithKline Biologicals’ rotavirus vaccine, RIX4414 when administered to HIV infected infants in South Africa.
    A.3.2Name or abbreviated title of the trial where available
    Rota-022
    A.4.1Sponsor's protocol code number444563/022
    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 number6.5
    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 assess the safety and reactogenicity of 3 doses of GSK Biologicals’ HRV vaccine versus placebo in HIV infected infants.
    E.2.2Secondary objectives of the trial
    To assess the immunogenicity (Geometric mean concentration (GMC), seroconversion, vaccine take) of the HRV vaccine in HIV infected infants two months after the third dose.
    To assess rotavirus shedding until it stops in HIV infected infants.
    To assess enteric pathogens in diarrhoeal stools.
    To assess the immune deficiency status (HIV viral load and CD4+ cell counts).
    To assess the immunogenicity of routine vaccines (DTPw-HBV/Hib + OPV) two months after the third dose.
    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 (e.g. completion of the diary cards, returned for the follow-up visits) were enrolled in the study.
    -A male or female between, and including 6 and 10 weeks of age at the time of the first vaccination.
    -Written informed consent obtained from the parents/guardians of the subject
    -Documented HIV status of the subject as confirmed by PCR.
    -HIV asymptomatic and HIV mildly symptomatic; Stage I and II disease according to WHO’s most recent classifi-cation for HIV stages in infants and children [30 Revised WHO clinical staging of HIV/AIDS for infants and children and 21 Guidelines for the management of HIV-infected children, 2005 or latest updated version].
    -Born after a gestation period of 36 to 42 weeks.
    E.4Principal exclusion criteria
    -Use of any investigational or non-registered drug or vac-cine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    -Previous routine vaccination except OPV, BCG and HBV vaccination at birth (should have been documented in the CRF).
    -Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
    -History of allergic disease or reaction 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 fever i.e. temperature more than or equal to 38.0°C (more than or equal to 37.5°C) as measured by a rectal (axillary) thermometer) (warrants deferral of the vaccination).
    -Gastroenteritis (diarrhoea) within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
    -Previous confirmed occurrence of RV gastroenteritis.
    -Other conditions which in the opinion of the investigator might have potentially interfered with interpretation of study outcomes.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of grade “2” or grade “3” fever, vomiting or diarrhoea within the 15-day solicited follow-up period after any doses.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 15 day after each dose
    E.5.2Secondary end point(s)
    Reactogenicity:
    For each type of solicited symptoms, occurrence of the symptom within the 15-day solicited follow-up period after each dose.
    Occurrence of unsolicited symptoms within 31 days after any dose according to MedDRA classification.
    Occurrence of SAEs throughout the study period.

    Evaluation of immune deficiency condition:
    CD4+ cell count
    HIV Viral load

    Immunogenicity:
    Seroconversion rate defined as the percentage of subjects with anti-rotavirus IgA antibody concentration greater than or equal to 20 U/ml in subjects initially negative for RV.
    Vaccine take rate (seroconversion or vaccine shedding)
    Serum rotavirus IgA antibody concentrations.
    GMC/Ts for anti-PRP, anti-diphtheria and anti-tetanus toxoids, anti-BPT, anti-HBs and anti-polio types 1, 2 and 3 antibodies.

    Seroprotection status:
    anti-PRP antibody concentrations more than or equal to 0.15 and 1.0 mcg/ml
    anti-diphtheria toxoid antibody concentrations more than or equal to 0.1 IU/ml
    anti-tetanus toxoid antibody concentrations more than or equal to 0.1 IU/ml
    anti-HBs antibody concentrations more than or equal to 10.0 mIU/ml
    anti-polio types 1, 2 and 3 antibody titres more than or equal to 8

    Seropositivity status:
    anti-BPT antibody concentrations 15 EL U/ml above the cut off level of the assay used
    RV shedding in stool samples by ELISA.
    RV typing and RV vaccine strain identification if G1 is identified (if applicable)
    Rotavirus in stool samples by ELISA.
    RV vaccine strain identification if applicable
    Bacteriology for enteric pathogens.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Solicited symptoms: 15 day follow-up after each dose, Unsolicited: 31 day follow-up after each dose, SAE's: Throughout the study period (Day 0-more than or equal to Month 4+7 days), CD4 count and HIV viral load: At the screening visit and Visit 4 (Month 4), Seroconversion rate, vaccine take rate and Serum rotavirus IgA antibody concentrations: 2 months after the 3rd dose of vaccine/ placebo, GMC/T for all antigens, seroportection status for anti-PRP, D, T, HBs and polio serotypes and seropositivity status for anti-BPT: 2 months after the 3rd dose of routine DTPw-HBV/Hib + OPV vaccines (Visit 4), RV shedding, typing and strain identity: Days 0, 7, 14 and 21 of Doses 1 and 2, Days 0, 7, 14, 28 and 42 of Dose 3, RV in stool, strain identity and bacteriology: Days 0, 7, 14, 28 and 42 of Dose 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    South Africa
    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 years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days27
    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: 100
    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: 100
    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 No
    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 100
    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: South Africa
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