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    Summary
    EudraCT Number:2013-003535-30
    Sponsor's Protocol Code Number:200147
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-10
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2013-003535-30
    A.3Full title of the trial
    A Phase III, double blind, randomized, comparative study of the safety and immunogenicity of GSK Biologicals’ Varilrix HSA-free varicella vaccine and Varilrix™ given as a 2 dose course in the second year of life
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A safety and immune study of 2 types of GlaxoSmithKline’s varicella vaccines given as a 2-doses course to healthy children 12-23 months of age
    A.3.2Name or abbreviated title of the trial where available
    OKAH-193
    A.4.1Sponsor's protocol code number200147
    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 VARILRIX
    D.2.1.1.2Name of the Marketing Authorisation holderSmithKline Beecham Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive attenuated varicella virus (OKA strain)
    D.3.9.3Other descriptive nameVARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED)
    D.3.9.4EV Substance CodeSUB21611
    D.3.10 Strength
    D.3.10.1Concentration unit log10 PFU/dose log10 plaque forming unit(s)/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.3
    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 VARILRIX
    D.2.1.1.2Name of the Marketing Authorisation holderSmithKline Beecham Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive attenuated varicella virus (OKA strain)
    D.3.9.3Other descriptive nameVARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED)
    D.3.9.4EV Substance CodeSUB21611
    D.3.10 Strength
    D.3.10.1Concentration unit log10 PFU/dose log10 plaque forming unit(s)/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.3
    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
    Vaccinating Healthy volunteers (Active immunization against varicella virus disease of healthy children in their second year of life).
    E.1.1.1Medical condition in easily understood language
    varicella virus disease
    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 demonstrate the safety profile (i.e. fever >39°C (>102.2°F)) of Varilrix HSA-free compared to Varilrix post Dose 1.
    Criteria:
    For the Varilrix HSA-free vaccine as compared to Varilrix, the upper limit of the 2-sided standardized asymptotic 95% CI for the group difference (Varilrix HSA-free minus Varilrix) in incidence of fever >39.0°C (>102.2°F) within 0-14 days after Dose 1 is equal to or below 5%.
    E.2.2Secondary objectives of the trial
    • To assess the safety and reactogenicity of Varilrix HSA-free and Varilrix after each vaccination
    • To assess fever ≥ 38.0°C (≥100.4°F) occurring from Day 0 through Day 14 after each vaccination
    • To assess fever ≥ 38.0°C (≥100.4°F) temporally associ-ated with serious adverse events (SAEs) occurring from Day 0 through Day 14 after each vaccination
    • To assess the immunogenicity of Varilrix HSA-free and Varilrix in terms of seroresponse and GMCs for anti-varicella antibodies (anti-VZV) at Visit 2/Day 42 and Visit 3/Day 84 in an immunogenicity sub-cohort of subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects’ parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
    • A male or female between, and including, 12 and 23 months of age (i.e. 12 months to a day before 24 months) at the time of the first study vaccination.
    • Written informed consent obtained from the par-ent(s)/LAR(s) of the subject prior to performing any study specific procedure.
    • Subjects in stable health as determined by investigator’s clinical examination and assessment of subject’s medical history.
    • Subjects must have had prior administration of a dose of measles, mumps and rubella (MMR) vaccine at least 30 days (Day -31 or earlier) prior to study vaccination at Day 0
    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 day of study vaccination (i.e., 30 days prior to Visit 1/Day 0) or planned use during the entire study period.
    •Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product.
    •Chronic administration (defined as 14 or more consecutive days) of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immuno-suppressive and immune-modifying drugs during the entire study.
     -For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day or equivalent.
     -Inhaled and topical steroids are allowed.
    •Planned administration/ administration of a live viral vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1/Day 0 until study end. Non study live viral vaccines can be administered at Visit 3 (Day 84) after completion of study procedures.
    •Planned administration/ administration of an inactivated vaccine not foreseen by the study protocol during the period starting 7 days prior to each vaccination (at Visit 1/Day 0 and Visit 2/Day 42) and ending 14 days after each vaccination. Outside of this period, non-study inactivated vaccines can be administered as per standard of care.
    •Administration of immunoglobulins and/or any blood prod-ucts during the period starting 180 days prior to the first vaccine dose or planned administration from the date of first study vaccination through the entire study.
    •History of varicella or zoster.
    •Known exposure to varicella/zoster during the period start-ing within 30 days prior to first study vaccination.
    •Previous vaccination against varicella.
    •Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history and physical examination (no laboratory testing required).
    •Subjects with blood dyscrasias, leukemia, and lymphomas of any type.
    •A family history of congenital or hereditary immunodefi-ciency
    •History of allergic disease or reactions likely to be exacer-bated by any component of the vaccines, including hyper-sensitivity to neomycin or latex.
    •Major congenital defects or serious chronic illness.
    •Acute disease and/or fever at the time of enrolment.
    - -Fever is defined as temperature ≥38. 0°C/100.4°F by any age appropriate route.
    - -Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
    •Active untreated tuberculosis based on medical history.
    •Any other condition which, in the opinion of the investigator, prevents the child from participating in the study
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of fever after varicella vaccination post Dose 1
    Criteria: Occurrence of fever > 39.0 °C (>102.2°F).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Day 0 through Day 14 after dose 1
    E.5.2Secondary end point(s)
    1. Assessment of fever after varicella vaccinations (Occurrence of fever ≥ 38.0°C (≥100.4°F)
    2. Immune response to varicella vaccine post dose 1 (Day 42) and post dose 2 (Day 84) (immuno-subcohort).
    3.Solicited local and general symptoms
    4. Unsolicited adverse events
    5. Serious adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From Day 0 through Day 14 after each vaccination
    2. 42 days after each vaccination
    3. From Day 0 to Day 3 after each vaccination for solicited local symptoms. 42 days after each vaccination for solicited general symptoms
    4. For 42 days after each vaccination day
    5. From Day 0 through the end of study (Day 0 - Day 84)
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Prevention
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Germany
    Mexico
    Thailand
    United Kingdom
    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.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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: 1220
    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: 1220
    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.4.1In the member state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 620
    F.4.2.2In the whole clinical trial 1220
    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)
    No plan for treatment or care after the subject has ended the participation in this trial is provided for prophylactic vaccine studies as the subjects are healthy and do not need any treatment or care after end of the study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-10-02
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-25
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