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    Summary
    EudraCT Number:2013-003155-38
    Sponsor's Protocol Code Number:116926
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-05-27
    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 number2013-003155-38
    A.3Full title of the trial
    A Phase III, double-blind, randomised, controlled, multi-country, multi-centre study to evaluate the immunogenicity and safety of GSK Biologicals’ quadrivalent influenza vaccine candidate, GSK2282512A (FLU Q-QIV), compared to GSK Biologicals’ trivalent influenza vaccine Fluarix®, administered intramuscularly to children 6 to 35 months of age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ quadrivalent influenza vaccine GSK2282512A when administered to children 6 to 35 months of age
    A.3.2Name or abbreviated title of the trial where available
    FLU Q-QIV-013
    A.4.1Sponsor's protocol code number116926
    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 No
    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 nameFLU Q-QIV
    D.3.2Product code GSK2282512A
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive nameH1N1 strain: A/California/7/2009(H1N1)pdm09-like virus
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive nameH3N2 strain: A/Victoria/361/2011(H3N2) like virus
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive nameB strain (Victoria lineage): B/Brisbane/60/2008 like virus
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive nameB strain (Yamagata lineage): B/Wisconsin/1/2010 like virus
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Fluarix
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals S.A
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive nameH1N1 strain: A/California/7/2009(H1N1)pdm09-like virus
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive nameH3N2 strain: A/Victoria/361/2011(H3N2) like virus
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive nameB strain (Yamagata lineage): B/Wisconsin/1/2010 like virus
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 (Immunisation against influenza in male and female subjects 6 to 35 months of age inclusive)
    E.1.1.1Medical condition in easily understood language
    Flu
    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 immunogenicity of FLU Q-QIV based on Center for Biologics Evaluation and Research’s (CBER)’s Seroconversion Rate (SCR) criterion for each of the four strains in children 6 to 35 months of age, approximately 28 days after completion of dosing (approximately Day 28 and Day 56 for primed and unprimed subjects, respectively).
    Criterion for determination of effective immunisation:
    The lower limit of the two-sided 95% confidence interval (CI) for SCR should be ≥ 40% for each strain.
    •To describe the reactogenicity of FLU Q-QIV and Fluarix in terms of solicited local and general adverse events (AEs), during a 7-day follow-up period.
    E.2.2Secondary objectives of the trial
    •To test the immunogenic superiority of the B/Victoria strain present in FLU Q-QIV [in terms of GMT and SCR] in all subjects ~ 28 days after completion of dosing (~ Day 28 and Day 56 for primed and unprimed subjects, respectively) by comparing FLU Q-QIV to Fluarix.

    Immunogenic superiority will be concluded if:
    -The lower limit of the two-sided 95% CI of the GMT ratio (FLU-Q-QIV/Fluarix®) is greater than 1.5, and
    -The lower limit of the two-sided 95% CI for the difference in SCR (FLU-Q-QIV – Fluarix®) is greater than 10%.
    •To describe the immunogenicity [in terms of GMTs, SPRs, SCRs and MGIs] of FLU Q-QIV and Fluarix®.
    •To describe the safety of FLU Q-QIV and Fluarix® in terms of:
    -Unsolicited AEs during the 28-day post-vaccination follow-up period (day of vaccination and 27 subsequent days).
    -SAEs, MAEs, and pIMDs during the entire study period.
    •To evaluate the relative risk of fever of FLU Q-QIV compared to Fluarix® during a 4-day follow-up period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subject’s 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.
    •A male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
    •Written informed consent obtained from the parent(s)/LAR(s) of the subject.
    •Subjects in stable health as determined by the investigator’s clinical examination and assessment of subject’s medical history.
    •Subjects are eligible regardless of history of administration of influenza vaccine in a previous season.
    E.4Principal exclusion criteria
    •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted.
    •Child in care
    •Prior receipt of any seasonal or pandemic influenza vaccine within six months preceding the first dose of study vaccine, or planned use during the study period.
    •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dosed.
    •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
    •History of Guillain-Barré syndrome within six weeks of receipt of prior influenza vaccine.
    •Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
    •Acute disease and/or fever at the time of enrolment.
    •Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
    •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
    •Any other condition which, in the opinion of the investiga-tor, prevents the subject from participating in the study.
    E.5 End points
    E.5.1Primary end point(s)
    A. Humoral immune response to each strain of FLU Q-QIV
    B. Occurrence of solicited local and general AEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    For A: 28 days after the last vaccine dose
    For B. During a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days)
    E.5.2Secondary end point(s)
    A. Serum anti-Haemagglutinin (HA) antibody titres against the four vaccine strains
    B. Occurrence of unsolicited AEs
    C. Occurrence of MAEs, SAEs, and pIMDs
    D. Occurrence of any fever or Grade 3 fever
    E.5.2.1Timepoint(s) of evaluation of this end point
    For A: On Day 0 and 28 days after last vaccine dose
    For B: During a 28-day follow-up period (i.e., day of vaccination and 27 subsequent days)
    For C: During the entire study period (Day 0 to Day 180)
    For D: During a 4-day follow-up period after dose 1 (Day 0) or dose 2 (Day 28)
    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) 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 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
    Canada
    Dominican Republic
    Honduras
    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 months6
    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: 601
    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: 401
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 200
    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 601
    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: Canada
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