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    Summary
    EudraCT Number:2012-001875-35
    Sponsor's Protocol Code Number:116566
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-04-17
    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 number2012-001875-35
    A.3Full title of the trial
    A phase III, randomized, open study to assess the immunogenicity, reactogenicity and safety of two different formulations of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, Rotarix, when given as a two-dose primary vaccination, in healthy infants with no previous history of rotavirus illness or vaccination.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity, reactogenicity and safety study of two different formulations of GSK Biologicals’ human rotavirus vaccine, Rotarix, in healthy infants.
    A.3.2Name or abbreviated title of the trial where available
    ROTA-083
    A.4.1Sponsor's protocol code number116566
    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 codeB-1330
    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
    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.3.1Product nameLiquid Human Rotavirus Vaccine
    D.3.4Pharmaceutical form 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 INNHuman rotavirus RIX4414 strain (live, attenuated)
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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
    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.3.1Product nameLyophilized Human Rotavirus Vaccine
    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 INNHuman rotavirus RIX4414 strain (live, attenuated)
    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 immunization of infants against gastroenteritis (GE) due to rotavirus (RV)].
    E.1.1.1Medical condition in easily understood language
    Diarrhea
    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
    1) To evaluate non-inferiority of GSK Biologicals' HRV liquid vaccine compared to GSK Biologicals' HRV lyophilized vaccine in terms of geometric mean concentrations (GMCs) for anti-RV antibodies, one month post dose 2 of HRV liquid vaccine and HRV lyophilized vaccine

    - Criterion: Non-inferiority will be stated if the lower limit of the two-sided 95% confidence interval (CI) for the ratio of anti RV IgA antibody GMCs between HRV liquid vaccine over the HRV lyophilized vaccine, one month after dose 2 is greater than or equal to 0.5.
    E.2.2Secondary objectives of the trial
    1)To assess the immunogenicity of the HRV liquid vaccine and HRV lyophilized vaccine, in terms of seroconversion* rates, one month post dose 2 of HRV vaccine
    *Seroconversion is defined as: for subjects with a pre-vaccination anti-RV IgA antibody concentration <20 U/mL, seroconversion is achieved when the post-vaccination concentration is ≥20 U/mL; for subjects with a pre-vaccination anti-RV IgA antibody concentration ≥20 U/mL, seroconversion is achieved when the post-vaccination concentration is ≥2 times the pre-vaccination concentration
    2)To assess the reactogenicity of the HRV liquid vaccine and the HRV lyophilized vaccine in terms of solicited adverse events (AEs), during the 8-day (Day 1–Day 8) follow-up period after each vaccination
    3)To assess the safety of the HRV liquid vaccine and the HRV lyophilized vaccine in terms of unsolicited AEs, during the 31-day (Day 1–Day 31) follow-up period after each vaccination and serious adverse events (SAEs), during the entire study period
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects’ parent(s)/ Legally Acceptable Representative (s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
    • Written informed consent obtained from the parent(s)/ LAR(s) of the subject prior to performing any study specific procedure.
    • A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination.
    • Healthy subjects as established by medical history and clinical examination before entering into the study.
    • Birth weight >2000 grams.

    E.4Principal exclusion criteria
    • Child in care.
    • Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccine (Day-29 to Day 1), or planned use during the study period.
    • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
    • Administration of any chronic drug therapy to be continued during the study period.
    • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine administration and ending at Visit 3; with the exception of the inactivated influenza vaccine, which is allowed at any time during the study, and other licensed routine childhood vaccinations, according to the local immunization practice.
    • 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.
    • History of confirmed RV GE.
    • Previous vaccination against RV.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, (including Severe Combined Immunodeficiency [SCID] disorder) based on medical history and physical examination.
    • Uncorrected congenital malformation (such as Meckel’s diverticulum) of the gastrointestinal tract that would pre-dispose for Intussusception (IS).
    • History of IS.
    • Very prematurely born infants (born ≤28 weeks of gestation).
    • Hypersensitivity to latex.
    • Family history of congenital or hereditary immunodeficiency.
    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
    • Major congenital defects or serious chronic illness.
    • History of any neurological disorders or seizures.
    • Acute disease and/or fever at the time of enrolment. This warrants deferral of vaccination.
    - Fever is defined as temperature >= 38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity, the axilla or the rectum.
    - Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
    • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history.
    • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
    • Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
    • GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination)
    E.5 End points
    E.5.1Primary end point(s)
    Anti-rotavirus (Anti-RV) immunoglobulin A (IgA) antibody concentrations
    E.5.1.1Timepoint(s) of evaluation of this end point
    One month post Dose 2 (Month 2; Visit 3) of HRV liquid vaccine and HRV lyophilized vaccine
    E.5.2Secondary end point(s)
    1) Percentage of seroconverted subjects for anti-RV IgA antibody
    2) Number of subjects reporting any solicited general adverse events (AEs)
    3) Number of subjects reporting any unsolicited AEs
    4) Number of subjects reporting any serious adverse events (SAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) One month post Dose 2 (Month 2; Visit 3) of HRV liquid vaccine and HRV lyophilized vaccine
    2) During the 8-day (Day 1-Day 8) follow-up period, after each dose of HRV liquid vaccine and HRV lyophilized vaccine.
    3) During the 31-day (Day 1-Day 31) follow-up period, after each dose of HRV liquid vaccine and HRV lyophilized vaccine.
    4) Throughout the study period (Dose 1 [Day1, Visit 1] up to study end [Month 2; Visit 3]).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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
    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
    Last testing results released for samples collected at Visit 3.
    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 days13
    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: 450
    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: 450
    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 450
    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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