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    Summary
    EudraCT Number:2015-001531-20
    Sponsor's Protocol Code Number:103860/280,101695,101696,/697,/698
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-06-26
    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 number2015-001531-20
    A.3Full title of the trial
    A phase III, single-blinded, randomized, multicentric study to compare the immunogenicity of GlaxoSmithKline Biologicals' thiomersal-free 2-dose Engerix™-B (20 mcg) and 3-dose preservative-free Engerix™-B (10 mcg) vaccines administered intramuscularly according to a 0, 6 month and 0, 1, 6 month schedule, respectively, and to evaluate safety and reactogenicity of each vaccine in healthy adolescent volunteers (11 to 15 years).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare the immunogenicity of GlaxoSmithKline Biologicals' thiomersal-free 2-dose Engerix™-B and 3-dose preservative-free Engerix™-B vaccines administered according to a 0, 6 month and 0, 1, 6 month schedule, respectively, and to evaluate safety and reactogenicity of each vaccine in healthy adolescent volunteers (11 to 15 years).
    A.3.2Name or abbreviated title of the trial where available
    HBV-280, HBV-303 EXT280 M30, HBV-304 EXT280 M42, HBV-305 EXT280 M54, HBV-306 EXT280 M66
    A.4.1Sponsor's protocol code number103860/280,101695,101696,/697,/698
    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 Engerix-B Junior
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals
    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.3.1Product nameEngerix-B Junior
    D.3.2Product code HBV Paediatric 10
    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 codeHBsAg
    D.3.9.3Other descriptive nameHEPATITIS B SURFACE ANTIGEN
    D.3.9.4EV Substance CodeSUB14083MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    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 Yes
    D.2.1.1.1Trade name Engerix-B Adult
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals
    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.3.1Product nameEngerix-B Adult
    D.3.2Product code HBV Adult 20
    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 codeHBsAg
    D.3.9.3Other descriptive nameHEPATITIS B SURFACE ANTIGEN
    D.3.9.4EV Substance CodeSUB14083MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hepatitis B vaccination of healthy adolescents.
    E.1.1.1Medical condition in easily understood language
    Infection of the liver leading to jaundice, liver failure and also liver cancer.
    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
    For the primary Epoch:
    To demonstrate non-inferiority of the immune response induced by (thiomersal-free) Engerix™-B (20 mcg HBsAg) administered as a 2-dose vaccination schedule compared to (preservative-free) Engerix™-B (10 mcg HBsAg) administered as a 3-dose vaccination schedule, one month after the full vaccination course (month 7).
    For the long term follow-up (LTFU):
    To evaluate anti-HBs antibody persistence at Months 30, 42, 54 and 66 after the first vaccine dose of primary vac-cination.
    E.2.2Secondary objectives of the trial
    At months 1, 2 and 6: anti-HBs titers for all subjects.
    Occurrence, intensity of solicited local signs and symptoms during a 4-day follow-up (i.e. the day of vaccination and the 3 subsequent days) after each vaccination and overall.
    Occurrence, intensity and relationship to vaccination of general signs and symptoms during a 4-day follow-up (i.e. the day of vaccination and the 3 subsequent days) after each vaccination and overall.
    Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms within 30 days after each vaccination and overall.
    Occurrence, intensity and relationship to vaccination of serious adverse events during the study period, up to and including 30 days post-vaccination.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A male or female between and including, 11 and 15 years of age at the time of the first vaccination.
    Written informed consent obtained from the subject and subject’s parent/guardian.
    Free of obvious health problems as established by medical history and clinical examination before entering the study.
    If the subject is female and of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
    Subjects should be seronegative for HBs antigen, anti-HBc antibodies and anti-HBs antibodies.
    E.4Principal exclusion criteria
    Use of any investigational or non-registered drug or vac-cine other than the study vaccines within 30 days preced-ing the first dose of study vaccine, or planned to use during the study period.
    Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
    Previous vaccination against hepatitis B.
    Known exposure to hepatitis B within the previous 6 weeks.
    History of hepatitis B infection.
    Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
    A family history of congenital or hereditary immunodeficiency.
    History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    Acute disease at the time of enrolment.
    Hepatomegaly, right upper quadrant abdominal pain or tenderness.
    Administration of immunoglobulins and any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
    Pregnant or lactating female.
    Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
    Any chronic drug therapy to be continued during the study period.
    Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
    Major congenital defects or serious chronic illness.
    History of chronic alcohol consumption and/or intravenous drug abuse.
    Female planning to become pregnant.
    E.5 End points
    E.5.1Primary end point(s)
    Anti- Hepatitis B surface antigen (HBs) titers.
    Anti-HBs seroprotection (SP) rates (defined as the proportion of subjects with anti-HBs antibody titres >=10 mIU/ml).
    Anti-HBs antibody persistence.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For seroprotection rate: At Month 7
    For anti-HBs antibody persistence: At Months 30, 42, 54 and 66.
    E.5.2Secondary end point(s)
    Anti-HBs titers for all subjects.
    Occurrence, intensity of solicited local signs and symptoms.
    Occurrence, intensity and relationship to vaccination of general signs and symptoms.
    Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms.
    Occurrence, intensity and relationship to vaccination of serious adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For anti-HBs titers for all subjects: At Months 1, 2 and 6
    For solicited local and general symptoms: During a 4-day follow-up (Day 0- Day 3) after each vaccination and overall.
    For unsolicited symptoms: Within 30 days (Day 0-Day 30) after each vaccination and overall.
    For serious adverse events: During the entire study period (Month 0 to Month 7).
    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 Yes
    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) 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 No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Australia
    Ukraine
    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 years5
    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: 384
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 384
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 384
    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: Australia
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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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