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    Summary
    EudraCT Number:2009-016911-39
    Sponsor's Protocol Code Number:113954
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-04-15
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2009-016911-39
    A.3Full title of the trial
    An open, phase IV, multicentre, study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in healthy children aged 11-12 years, previously vaccinated with GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) or GSK Biologicals’ DTPa-IPV/Hib and HBV (Engerix™- B) vaccines at the ages of 3, 5 and 11 months in clinical trial DTPa-HBV-IPV-031 (217744/031).
    A.3.2Name or abbreviated title of the trial where available
    DTPa-HBV-IPV-126 BST:031
    A.4.1Sponsor's protocol code number113954
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 10ug
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals
    D.2.1.2Country which granted the Marketing AuthorisationSlovakia
    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
    D.3.2Product code JO7BC01
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 B surface antigen
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Antibody persistence and hepatitis B vaccine challenge at 11-12 years of age (excluding 13th birthday), after primary vaccination with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) or GSK Biologicals’ HBV vaccine (Engerix-B) given at the ages of 3, 5 and 11 months.
    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 assess the anti-HBs antibody response to a challenge dose of HBV vaccine in subjects aged 11-12 years, vaccinated in infancy with three doses of Infanrix hexa or Engerix-B at 3, 5 and 11 months of age.
    E.2.2Secondary objectives of the trial
    •To assess the persistence of anti-HBs antibodies, 10-11 years after primary infant vaccination with three doses of Infanrix hexa or Engerix-B at 3, 5 and 11 months of age.
    •To evaluate the safety and reactogenicity of a challenge dose of HBV vaccine in terms of solicited symptoms, unsolicited symptoms and serious adverse events (SAEs).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects must satisfy ALL the following criteria at study entry:
    •Subjects who the investigator believes that their parents/LAR(s) can and will comply with the requirements of the protocol (return for follow-up visits) should be enrolled in the study.
    •A male or female aged 11-12 years at the time of study entry (from and including the 11th birthday until and excluding the 13th birthday).
    •Written informed consent obtained from the parent or LAR of the subject.
    •Study procedures will be explained to subjects and depending on their understanding, optional informed assent will be sought at the discretion of the investigator.
    •Written informed assent obtained from the subject (the study purpose and procedures will be explained to the subject by appropriately trained personnel) in addition to the informed consent signed by the parent(s)/LAR(s).
    •Healthy subjects as established by medical history and clinical examination before entering into the study.
    •Subjects who have received all three doses of Infanrix hexa or Engerix-B in the primary study DTPa-HBV-IPV-031.
    •Female subjects of non-childbearing potential may be enrolled in the study.
    Non-childbearing potential is defined as pre-menarche, current tubal ligation, 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 2 months after completion of the vaccination series.

    E.4Principal exclusion criteria
    The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included 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 product (pharmaceutical product or device).
    •Child in care.
    •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the challenge dose of HBV vaccine, or planned use during the study period.
    •Receipt of hepatitis B (containing) vaccine after vaccination in the primary study DTPa-HBV-IPV-031.
    •History of hepatitis B disease.
    •Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the HBV vaccine challenge dose.
    •Administration of immunoglobulins and/or any blood products within the three months preceding the challenge dose of HBV vaccine or planned administration during the study period.
    •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of HBV vaccine. For corticosteroids, this will mean prednisone <20 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
    •Pregnant or lactating female.
    •Female planning to become pregnant or planning to discontinue contraceptive precautions.
    •Known hypersensitivity to any component of the HBV vaccine or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
    •Acute disease and/or fever at the time of enrolment.
    •Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting
    Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    •Anti-HBs antibody concentrations one month after a challenge dose of HBV vaccine: Percentage of subjects with anti-HBs antibody concentrations greater than or equal to 100 mIU/ml.
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    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) 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 concerned12
    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 Information not present in EudraCT
    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
    The end of the trial is defined as one month after the administration of the booster dose.
    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 months7
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.1.6Adolescents (12-17 years) Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In addition to the informed consent that is to be signed by subject’s parent(s)/LAR(s) and, depending on the subject’s understanding, informed assent will be taken at the discretion of the investigator.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state309
    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)
    The subjects are healthy and there are no plans for further treatment or care of the study subjects once they have finalized participation.
    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 Decision2010-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
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