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    Summary
    EudraCT Number:2013-001918-15
    Sponsor's Protocol Code Number:116763
    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:2014-04-25
    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 number2013-001918-15
    A.3Full title of the trial
    A phase IV, open-label, single-centre study to assess the long-term persistence of hepatitis A antibodies in healthy adults, primed 21 to 25 years earlier with GSK Biologicals’ hepatitis A vaccine Havrix® (SB208109) in studies HAV-112 (208109/108) or HAV-123 (208109/114).

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the long-term persistence of hepatitis A antibodies in healthy adults who were vaccinated 21-25 years earlier with GlaxoSmithKline (GSK) Biologicals’ hepatitis A vaccine, Havrix®.
    A.3.2Name or abbreviated title of the trial where available
    HAV-248
    A.4.1Sponsor's protocol code number116763
    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 Havrix 1440 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 nameHavrix 1440 Adult
    D.3.2Product code HAV 1140
    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 INNHepatitis A (inactivated)
    D.3.9.2Current sponsor codeHAV Antigen
    D.3.9.3Other descriptive nameHEPATITIS A VIRUS ANTIGEN (INACTIVATED)
    D.3.9.4EV Substance CodeSUB38555
    D.3.10 Strength
    D.3.10.1Concentration unit ELISA unit/ml enzyme-linked immunosorbent assay unit/millitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1440
    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 (Vaccination against hepatitis A in healthy adults)
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10052551
    E.1.2Term Hepatitis A virus
    E.1.2System Organ Class 100000004848
    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 persistence of anti-HAV antibodies in terms of seropositivity rate and geometric mean concentration (GMC), 21 to 25 years after the second vaccine dose.
    E.2.2Secondary objectives of the trial
    Occurrence of serious adverse events (SAEs) related to study participation, or to the study vaccine administered in the primary studies HAV-112 (208109/108) or HAV-123 (208109/114), during the entire study period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A male or female who received two doses of Havrix in study HAV-112 (208109/108) or HAV-123 (208109/114), and received no further booster dose since then.
    Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
    Written informed consent obtained from the subject.
    E.4Principal exclusion criteria
    • History of hepatitis A disease since completion of the primary vaccination series in studies HAV-112 (208109/108) or HAV-123 (208109/114).
    • Administration of a hepatitis A vaccine at any time since completion of the primary vaccination series in studies HAV-112 (208109/108) or HAV-123 (208109/114) including a challenge dose of the study vaccine, as a part of the study procedures, during the long-term persistence phase.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
    • Administration of hepatitis A immunoglobulins and/or any blood products and/or long-acting immune-modifying drugs within six months prior to study entry.
    • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry. For corticosteroids, this will mean prednisone >=20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
    • Administration of long-acting immune-modifying drugs within six months prior to study entry (e.g. infliximab).
    • Concurrently participating in another clinical study, during the period starting 30 days before and ending 30 days after each study visit, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity with respect to components of the study vaccine in terms of anti-HAV seropositivity status and GMCs
    -Anti-HAV seropositivity status and antibody concentrations
    E.5.1.1Timepoint(s) of evaluation of this end point
    21 to 25 years after the second vaccine dose
    E.5.2Secondary end point(s)
    Occurrence of serious adverse events (SAEs).
    Occurrence of SAEs related to study participation or to the study vaccine administered in the primary studies HAV-112 (208109/108) or HAV-123 (208109/114)
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the entire study period (Year 21 to Year 25)
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years5
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days2
    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: 120
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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.4.1In the member state120
    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 Decision2014-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-28
    P. End of Trial
    P.End of Trial StatusCompleted
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