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    Summary
    EudraCT Number:2011-004734-33
    Sponsor's Protocol Code Number:109825
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-04-12
    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 number2011-004734-33
    A.3Full title of the trial
    A Phase II, non-randomised, open-label study to evaluate the safety and immunogenicity of the adjuvanted (pre-) pandemic H5N1 influenza candidate vaccine following a heterologous prime-boost schedule (six months apart) in children aged 6 to 35 months.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and immunogenicity of GSK Biologicals’ (pre-) pandemic influenza vaccine in children aged 6 to 35 months.
    A.3.2Name or abbreviated title of the trial where available
    H5N1-013
    A.4.1Sponsor's protocol code number109825
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/147/2011
    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 number442289904466
    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 nameH5N1 A/turkey/Turkey/1/2005 with AS03B
    D.3.2Product code GSK1562902A
    D.3.4Pharmaceutical form Emulsion and suspension for emulsion 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.3.9.3Other descriptive nameA/Turkey/Turkey/1/2005 (H5N1)
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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 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 nameH5N1 A/Indonesia/05/2005 with AS03B
    D.3.2Product code GSK1562902A
    D.3.4Pharmaceutical form Emulsion and suspension for emulsion 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.3.9.3Other descriptive nameA/INDONESIA/05/2005 (H5N1) - LIKE STRAIN
    D.3.9.4EV Substance CodeSUB30758
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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
    Immunisation of healthy children aged 6 to 35 months against H5N1 influenza.
    E.1.1.1Medical condition in easily understood language
    Immunisation against influenza in healthy children 6-35 months.
    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 whether a heterologous booster dose of 1.9 µg A/turkey/Turkey/1/2005 (H5N1) HA with AS03B given 6 months following a 2-dose primary vaccination series with 1.9 µg A/Indonesia/05/2005 (H5N1) HA with AS03B elicits an antibody response that meets the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) guidance targets for pre-pandemic vaccine seroconversion rate (SCR), seroprotection rate (SPR) and mean geometric increase (MGI) based on HI responses to A/turkey/Turkey/1/2005 (H5N1) ten days following booster vaccination.
    E.2.2Secondary objectives of the trial
    • To assess the HI response against A/Indonesia/05/2005 and A/turkey/Turkey/1/2005 strains in terms of seropositivity rates, geometric mean titres (GMTs), SCRs, SPRs and MGIs on Day 0, Day 42, Day 182, Day 192 and Day 364.
    • To further describe the humoral immune responses in terms of the three age strata used for enrolment in this study.
    • To describe, in all subjects, the H5N1 neutralising antibody responses against A/Indonesia/05/2005 and A/turkey/Turkey/1/2005 strains on Day 0, Day 42, Day 182, Day 192 and Day 364.
    • To evaluate, after the primary vaccinations and the booster administration, the safety and reactogenicity of the H5N1 vaccines in terms of 7-day solicited local and general adverse events (AEs), unsolicited AEs for 21 days after each dose and from Day 0 to the phone call on Day 84 overall, and medically-attended AEs (MAEs), potential Immune-Mediated Diseases (pIMDs), and serious adverse events (SAEs) during the entire study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol.
    • Children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination.
    • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
    • Healthy children as established by medical history and clinical examination before entering the study.
    • Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
    • Subjects who are likely to reside in the vicinity of the study centre for the duration of the study. In studies using the home-based model for vaccination and follow-up, subjects who are likely to remain in the vicinity of the area where they were recruited.
    E.4Principal exclusion criteria
    • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days 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 dose.
    • Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
    • History of any neurological disorders or seizures.
    • Acute disease at the time of enrolment.
    • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
    • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned administration during the study period.
    • Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
    • Child in care.
    • Previous vaccination at any time with an H5N1 vaccine.
    • Medical history of physician-confirmed infection with a H5N1 virus.
    E.5 End points
    E.5.1Primary end point(s)
    Humoral immune response in terms of H5N1 HI antibodies against A/turkey/Turkey/1/2005 H5N1 virus strain.

    Observed variable:
    H5N1 HI antibody titres against A/turkey/Turkey/1/2005 H5N1 virus strain on Day 192.
    E.5.1.1Timepoint(s) of evaluation of this end point
    On Day 192
    E.5.2Secondary end point(s)
    Humoral immune response in terms of H5N1 HI antibodies against A/Indonesia/05/2005 and A/turkey/Turkey/1/2005 H5N1 virus strains.
    Observed variable:
    • H5N1 HI antibody titres against A/Indonesia/05/2005 and A/turkey/Turkey/1/2005 virus strains on Day 0, Day 42, Day 182, Day 192 and Day 364.
    Humoral immune response in terms of neutralising antibodies against A/Indonesia/05/2005 and A/turkey/Turkey/1/2005 H5N1 virus strains:
    Observed variable:
    • Serum neutralising antibody titres against A/Indonesia/05/2005 and A/turkey/Turkey/1/2005 virus strains on Day 0, Day 42, Day 182, Day 192 and Day 364.
    For the safety and reactogenicity evaluation:
    • Percentage, intensity and relationship to vaccination of solicited local and general AEs during a 7-day follow-up period, i.e. day of vaccination and six subsequent days after each vaccination on Day 0, Day 21 and Day 182.
    • Percentage, intensity and relationship to vaccination of unsolicited AEs during a 21-day follow-up period after each vaccination and from Day 0 to Day 84 overall.
    • Occurrence of MAEs during the entire study period.
    • Occurrence of pIMDs during the entire study period.
    • Occurrence of SAEs during the entire study period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity with respect to components of the investigational vaccine - On Day 0, Day 42, Day 182, Day 192 and Day 364.

    Immunogenicity with respect to components of the investigational vaccine in terms of neutralising antibodies - On Day 0, Day 42, Day 182, Day 192 and Day 364.

    Occurrence of solicited local and general adverse events - During a 7-day (Day 0-6) follow-up period after each vaccination.

    Occurrence of unsolicited AEs - During a 21-day (Day 0-20) follow-up period after each vaccination and from Day 0 to Day 84 overall.

    Occurrence of medically-attended adverse events (MAEs), potential Immune-Mediated Diseases (pIMDs) and serious adverse events (SAEs) - During the entire study period (Day 0-364).
    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
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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
    Australia
    Singapore
    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 subject/last visit
    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 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: 120
    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: 90
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    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 120
    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)
    A plan for treatment or care after the subject has ended the participation in this trial is not 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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Singapore
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