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    Summary
    EudraCT Number:2015-001258-13
    Sponsor's Protocol Code Number:111751
    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 number2015-001258-13
    A.3Full title of the trial
    A phase III, observer-blind, multi-centre, multi-country, randomized study to evaluate the immunogenicity and safety of thimerosal-free (TF) Fluarix™ (GSK Biologicals) compared with Fluzone® (Sanofi Pasteur) administered intramuscularly in 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 the immunogenicity and safety of GSK Biologicals’ thimerosal-free TIV Flu vaccine versus a licensed comparator in children
    A.3.2Name or abbreviated title of the trial where available
    FLUARIX US-007
    A.4.1Sponsor's protocol code number111751
    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 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.3.9.2Current sponsor codeA/Brisbane/59/2007 (H1N1) (IVR-148)
    D.3.9.3Other descriptive nameTRIVALENT INACTIVATED INFLUENZA VACCINE
    D.3.9.4EV Substance CodeSUB129647
    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.3.9.2Current sponsor codeA/Uruguay/716/2007 (H3N2) NYMC X-175C)
    D.3.9.3Other descriptive nameTRIVALENT INACTIVATED INFLUENZA VACCINE
    D.3.9.4EV Substance CodeSUB129647
    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.3.9.2Current sponsor codeB/Brisbane/3/2007
    D.3.9.3Other descriptive nameTRIVALENT INACTIVATED INFLUENZA VACCINE
    D.3.9.4EV Substance CodeSUB129647
    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 Fluzone®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.9.2Current sponsor codeA/Brisbane/59/2007 (H1N1) (IVR-148)
    D.3.9.3Other descriptive nameTRIVALENT INACTIVATED INFLUENZA VACCINE
    D.3.9.4EV Substance CodeSUB129647
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.2Current sponsor codeA/Uruguay/716/2007 (H3N2) (NYMC X-175C)
    D.3.9.3Other descriptive nameTRIVALENT INACTIVATED INFLUENZA VACCINE
    D.3.9.4EV Substance CodeSUB129647
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.2Current sponsor codeB/Brisbane/3/2007
    D.3.9.3Other descriptive nameTRIVALENT INACTIVATED INFLUENZA VACCINE
    D.3.9.4EV Substance CodeSUB129647
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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
    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 demonstrate the immunological non-inferiority (in terms of GMTs and seroconversion rates) of TF Fluarix (0.5mL) versus Fluzone (0.25mL) in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial IM vaccination.
    •To demonstrate the immunological non-inferiority (in terms of GMTs and seroconversion rates) of TF Fluarix (0.25mL) versus Fluzone (0.25mL) in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial IM vaccination
    E.2.2Secondary objectives of the trial
    •To compare local and general solicited AEs, unsolicited AEs, and serious AEs in subjects vaccinated with TF Fluarix (0.5mL) or TF Fluarix (0.25mL) or Fluzone, by dose for solicited AEs only and overall for all AE types.
    •To compare the immunogenicity of TF Fluarix (0.5mL) to TF Fluarix (0.25mL) and Fluzone pre- and post-vaccination at approximately 28 or 56 days (GMTs, seroconversion rate, seroprotection and seroconversion factor).
    •To detect rare events, defined as serious adverse events with an occurrence rate of 1/300, in subjects (6 to 35 months of age) vaccinated with each administered volume of TF Fluarix
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •A male or female child aged 6 to 35 months at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season were acceptable.
    •Subjects having a parent/LAR (Legally Appointed Repre-sentative) who the investigator believed could and would comply with the requirements of the protocol (e.g., return their child for follow-up visit and completion of diary cards) were to be enrolled in the study.
    •Written informed consent obtained from the subject’s parent/LAR.
    E.4Principal exclusion criteria
    •Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations were not an exclusion criterion.
    •History of hypersensitivity to any vaccine.
    •History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, gentamicin sulfate or sodium deoxycholate.
    •Acute disease at the time of enrolment. (Acute disease was defined as the presence of a moderate or severe illness with or without fever. All vaccines could be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/axillary temperature <37.5°C (99.5°F) or rectal temperature <38.0°C (100.4°F).
    •History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
    •Receipt of an influenza vaccine outside of this study, during current (2008-09) flu season.
    •Administration of immunoglobulins and/or blood products within the 3 month period preceding the first dose of study vaccine or planned administration during the study period.
    E.5 End points
    E.5.1Primary end point(s)
    Serum anti-HA antibody titer against each of the three vaccine strains. The following parameters (with 95% CI) were to be calculated for each treatment group:
    •Geometric Mean Titre (GMT) at post-vaccination timepoint
    •Seroconversion rate (SCR), defined as the proportion of subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination titer > or = 1:40, or a pre-vaccination titer > or = 1:10 and a minimum 4-fold increase at post-vaccination titer
    E.5.1.1Timepoint(s) of evaluation of this end point
    At pre-vaccination (Day 0) and at post-vaccination (Day 28 for primed or Day 56 for unprimed subjects)
    E.5.2Secondary end point(s)
    1) Serum anti-HA antibody titer against each of the three vaccine strains. The following parameters (with 95% CI) were to be calculated for each treatment group:
    • Seroprotection rate (SPR) at pre and post-vaccination time-points
    • Seroconversion factor (SCF)
    2) Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms
    3) Percentage, intensity and relationship to vaccination of unsolicited symptoms
    4) Occurrence of serious adverse events and new onset of chronic illnesses
    5) Occurrence of rare serious events (an occurrence rate of 1/300)
    E.5.2.1Timepoint(s) of evaluation of this end point
    For 1): At pre-vaccination (Day 0) and at post-vaccination (Day 28 for primed or Day 56 for unprimed subjects)
    For 2): During a 4-day follow-up period (i.e. day of vaccination and 3 subsequent days) after each vaccination
    For 3): During the 28-day follow-up period(s) after each vaccination
    For 4): During the entire study period
    For 5): During the entire study period
    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) 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 No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    observer-blind
    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
    Hong Kong
    Mexico
    Taiwan
    Thailand
    United States
    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 months8
    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: 3318
    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: 2212
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 1106
    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 3318
    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: Thailand
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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