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    Summary
    EudraCT Number:2015-001514-97
    Sponsor's Protocol Code Number:114541
    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 number2015-001514-97
    A.3Full title of the trial
    A Phase 3, observer blind, randomized, non-influenza vaccine comparator-controlled, multi-country and multi-centre study of the efficacy of GSK Biologicals’ quadrivalent, inactivated, split virion, seasonal influenza vaccine candidate, GSK2282512A (FLU Q-QIV), administered intramuscularly in healthy children 3 to 8 years of age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy of GSK Biologicals’ quadrivalent influenza vaccine, GSK2282512A, (FLU Q-QIV) when administered in children 3 to 8 years of age
    A.3.2Name or abbreviated title of the trial where available
    FLU Q-QIV-006 PRI
    A.4.1Sponsor's protocol code number114541
    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 NYMC X-179A
    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/210/2009 NYMC X-187
    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
    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/Florida/4/2006
    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 Havrix 720 Junior
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals S.A
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 codeHAV Antigen
    D.3.9.3Other descriptive nameHEPATITIS A VIRUS (INACTIVATED)
    D.3.9.4EV Substance CodeSUB20081
    D.3.10 Strength
    D.3.10.1Concentration unit ELISA unit/dose enzyme-linked immunosorbent assay unit/dose
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number720
    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 (Immunization against influenza in male and female subjects 3 to 8 years 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 evaluate the efficacy of Q-QIV in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR) confirmed influenza A and or B disease presenting as influenza like illness (ILI), compared to a non-influenza vaccine comparator (Havrix) in children 3 to 8 years of age.
    Influenza-like illness (ILI) was defined as the presence of an oral or axillary temperature ≥37.8° C in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of Q-QIV in the prevention of moderate to severe cases of influenza confirmed by RT-PCR, compared to Havrix.
    •To evaluate the efficacy of Q-QIV (when compared to Havrix) in the prevention of culture-confirmed influenza A and/or B disease due to seasonal influenza strains anti-genically matching the vaccine strains.
    •To describe the immunogenicity (geometric mean titer, seroconversion rate, seroconversion factor and seroprotection rate) of Q-QIV 28 days after completion of vaccination in a subset of subjects.
    •To assess the reactogenicity/safety of Q-QIV in terms of:
    -Solicited local and general symptoms during 7 days of follow-up (day of vaccination and 6 sub-sequent days) after each vaccination
    -Unsolicited symptoms during 28 days of follow-up (day of vaccination and 27 subsequent days) after each vaccination
    -Serious adverse events , medically attended adverse events and potential immune-mediated diseases throughout the entire study period
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subjects who the investigator believed that they and/or their parent(s) or Legally Acceptable Representative(s) (LAR) could and would comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, respects intervals between study visits).
    •A male or female child aged between 3 years and 8 years inclusive (i.e., not having attained the 9th birthday) at the time of the first vaccination; children were eligible regardless of history of administration of influenza vaccine in a previous season. However, subjects who had received any seasonal or pandemic influenza vaccine (registered or investigational) within 6 months preceding the first dose of study vaccine would not be enrolled.
    •Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
    •Written assent obtained from the subject if/as required by local regulations.
    •Subjects in stable health as determined by investigator’s clinical examination and assessment of subjects’ medical history.
    •Access to a consistent means of telephone contact
    E.4Principal exclusion criteria
    •Child in care (i.e., a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian)
    •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations were permitted.
    •Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period.
    •Prior receipt of more than one dose of a licensed hepatitis A vaccine, with the first dose administered at ≥12 months of age.
    •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this was a dose equivalent to either > 2 mg/kg of body weight or maximum of 20 mg/day of pred-nisone or equivalent when administered for > 2 weeks. Inhaled and topical steroids were allowed.
    •Administration of immunoglobulins and/or any blood prod-ucts within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
    •History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine.
    •Any known or suspected allergy to any constituent of in-fluenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
    •Fever (temperature >= 38.0°C or 100.4°F by any method) at the time of enrolment.
    •Acute disease (moderate or severe illness) at the time of enrolment.
    •Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
    •Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history and physical examination.
    •Ongoing aspirin therapy (to avoid potential cases of Reye’s syndrome).
    •Any other condition which, in the opinion of the Investigator, prevented the subject from participating in the study
    E.5 End points
    E.5.1Primary end point(s)
    RT-PCR-confirmed influenza A and/or B disease. The primary endpoint required a positive RT-PCR result for influenza A or B virus from a nose and throat swab obtained concurrently with ILI (influenza like illness)
    E.5.1.1Timepoint(s) of evaluation of this end point
    First occurrence of outcome
    E.5.2Secondary end point(s)
    A. RT-PCR confirmed moderate to severe influenza A and/or B during the influenza surveillance period.
    Moderate to severe influenza defined as RT-PCR-confirmed ILI (influenza like illness) with:
    -Fever >39 degree Celsius (39°C), and/or at least one of the following manifestations,
    -Physician-verified shortness of breath, pulmonary congestion, pneumonia, bronchiolitis, bronchitis, wheezing, croup, or acute otitis media, and/or one of the following,
    -Physician-diagnosed serious extra-pulmonary com-plication of influenza, including myositis, encephalitis, seizure, or myocarditis

    B. Culture-confirmed influenza A and/or B disease (as defined in the primary outcome/efficacy variable) antigenically-matching with the influenza strains, during the influenza surveillance period

    C. Culture-confirmed influenza A and/or B disease (as defined in the primary outcome/efficacy variable) due to any influenza strains, during the influenza surveillance period

    D. Occurrence, intensity, and relationship to vaccination of solicited local and general adverse events AE(s)

    E. Occurrence, intensity and relationship to vaccination of unsolic-ited AE(s)

    F. Occurrence and relationship to vaccination of serious adverse events (SAEs), medically attended adverse events (MAEs), and potential immune-mediated diseases (pIMDs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    First occurrence of outcome (for A, B, and C)
    During a 7-day follow-up period after each vaccination (for D)
    During a 28 day follow-up period after each vaccination (for E)
    During the entire study (for F)
    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
    Bangladesh
    Dominican Republic
    Honduras
    Lebanon
    Panama
    Philippines
    Thailand
    Turkey
    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 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: 5175
    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) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 5175
    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 5200
    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: Turkey
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