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    Summary
    EudraCT Number:2015-004099-31
    Sponsor's Protocol Code Number:116811
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-16
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-004099-31
    A.3Full title of the trial
    Long-term persistence of immunity to hepatitis B in adults vaccinated 20 to 30 years ago with Engerix™-B.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term persistence of immunity to hepatitis B in adults vaccinated with GlaxoSmithKline (GSK) Biologicals’ hepatitis B vaccine (HBV), Engerix™-B.
    A.3.2Name or abbreviated title of the trial where available
    HBV-322
    A.4.1Sponsor's protocol code number116811
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01627340
    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 number+442089904466
    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 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/ml microgram(s)/millilitre
    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
    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 infection caused by all known subtypes of hepatitis B virus).
    E.1.1.1Medical condition in easily understood language
    Inflammation of the liver due to viral infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10019731
    E.1.2Term Hepatitis B
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 persistence of immunity to hepatitis B in terms of anti-HBs anamnestic response to an Engerix-B challenge dose, in adult subjects vaccinated with three or four doses of Engerix-B 20 to 30 years ago.
    E.2.2Secondary objectives of the trial
    - To assess the persistence of immunity to hepatitis B in terms of Geometric Mean Concentrations (GMCs), seropositivity rates, seroprotection rates, and percentage of subjects with anti-HBs antibody concentrations ≥ 100 mIU/mL, before or after the Engerix-B challenge dose, in subjects vaccinated with three or four doses of Engerix-B 20 to 30 years ago.
    - To assess the persistence of immunity to hepatitis B in terms of T cell and memory B cell mediated immune responses specific to hepatitis B surface antigen, before and after the Engerix-B challenge dose, in adult subjects vaccinated with three or four doses of Engerix-B 20 to 30 years ago.
    - To evaluate the safety and reactogenicity of Engerix-B challenge dose in terms of solicited symptoms, un-solicited symptoms and serious adverse events (SAEs).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
    - A male or female between and including 40 and 60 years of age (from and including the 40th birthday up to, but excluding, the 61st birthday) at the time of the vaccination.
    - Written informed consent obtained from the subject.
    - Documented evidence of previous vaccination with three or four consecutive doses of Engerix-B administered in adulthood (i.e. at least 18 years of age) with
    - the last dose received 4 to 12 months after the previous one,
    - no subsequent booster dose ever received later, and
    - the last dose received 20 to 30 years before enrolment.
    - Female subjects of non-childbearing potential may be enrolled in the study.
    - Non-childbearing potential is defined as pre-menarche, hysterectomy, ovariectomy or post-menopause.
    - Female subjects of childbearing potential may be enrolled in the study, if the subject:
    - has practiced adequate contraception for 30 days prior to vaccination, and
    - has a negative pregnancy test on the day of vaccination, and
    - has agreed to continue adequate contraception during the entire treatment period and for one month after vaccination.
    E.4Principal exclusion criteria
    - Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the 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 vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
    - Administration of long-acting immune-modifying drugs at any time during the study period.
    - Previous hepatitis B booster vaccination since completion of the primary vaccination series with three or four doses of Engerix-B.
    - Planned administration of a vaccine not foreseen by the study protocol within 30 days preceding the dose of study vaccine, or planned administration during the study period, with the exception of seasonal influenza vaccine.
    - Any medical condition that in the judgment of the investigator places the subject at undue risk by participating in the study.
    - Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
    - History of hepatitis B disease or episode of jaundice with unknown etiology.
    - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
    - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
    - Major congenital defects or serious chronic illness (including insulin-dependent diabetes).
    - Acute disease and/or fever at the time of enrolment.
    -Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or 38.0°C on rectal route.
    - Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
    - Administration of immunoglobulins and/or any blood products during the period starting 3 months before the dose of study vaccine, or planned administration during the study period.
    - Drug and/ or alcohol abuse within the last 5 years.
    E.5 End points
    E.5.1Primary end point(s)
    Persistence of immunity to hepatitis B in adult subjects vaccinated with three or four doses of Engerix-B 20 to 30 years ago.
    - Percentage of adult subjects with an anamnestic response.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days and 30 days after the challenge dose (Day 7 and day 30).
    E.5.2Secondary end point(s)
    Persistence of immunity to hepatitis B in adult subjects vaccinated with three or four doses of Engerix-B 20 to 30 years ago.
    - Percentage of adult subjects with anti-HBs antibody concentrations ≥ 6.2 mIU/ml, ≥ 10 mIU/ml and ≥ 100 mIU/ml
    - Anti-HBs antibody concentrations.
    - Hepatitis B specific memory B cell-mediated immune responses (frequency of HBs-specific memory B cells) .
    - Hepatitis B specific T cell-mediated immune responses (frequency of HBs-specific CD4 T-lymphocytes).
    Solicited local and general symptoms.
    Unsolicited adverse events.
    Serious adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Persistence of immunity to hepatitis B in adult subjects vaccinated with three or four doses of Engerix-B 20 to 30 years ago a the pre-challenge dose timepoint (Day 0), Day 7 post-challenge time-point (Day 7) and Day 30 post-challenge dose time-point (Day 30).
    - Solicited local and general symptoms during the 4-day (Days 0-3) follow-up period after the challenge dose.
    - Unsolicited adverse events during the 31-day (Days 0-30) follow-up period after the challenge dose.
    - Serious adverse events after the challenge dose up to study end (up to Day 30).
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    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.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    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.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 100
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-26
    P. End of Trial
    P.End of Trial StatusCompleted
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