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    Summary
    EudraCT Number:2012-001344-22
    Sponsor's Protocol Code Number:116640
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-01-16
    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 number2012-001344-22
    A.3Full title of the trial
    A phase II, randomised, single-blind study to develop read-outs aimed at detecting and characterising the early and adaptive immune responses and to evaluate the kinetics of the early response and reactogenicity in healthy, hepatitis B virus naive adults vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals’ Adjuvant System
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Development of read-outs in healthy, hepatitis B virus naive adults vaccinated with the hepatitis B surface antigen (HBsAg) in combination with a GlaxoSmithKline (GSK) Biologicals’ Adjuvant System.
    A.3.2Name or abbreviated title of the trial where available
    EARLY-CLINRES-008
    A.4.1Sponsor's protocol code number116640
    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.4.1Name of organisation providing supportRegion Wallonne
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportInstitute for Medical Immunology (Université Libre de Bruxelles)
    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 pointClincical 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 nameHepatitis B surface antigen (HBsAg) candidate vaccine adjuvanted with AS01B
    D.3.4Pharmaceutical form Powder and solvent for 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 B SURFACE ANTIGEN
    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.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 ENGERIX-B
    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
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    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.3.9.3Other 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
    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
    Healthy volunteers (Hepatitis B surface antigen (HBsAg) vaccine administered in hepatitis B virus (HBV) naive adult subjects aged between 18 and 45 years old, inclusive, in good general health.)
    E.1.1.1Medical condition in easily understood language
    Infections caused by the hepatitis B virus
    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 detect and measure soluble mediators from the early immune response in plasma.
    E.2.2Secondary objectives of the trial
    •To evaluate the antibody response induced by GSK Biologicals’ adjuvanted investigational vaccine or by Engerix-B.
    •To evaluate the magnitude of the T-cell immune response induced by GSK Biologicals’ adjuvanted investigational vaccine or by Engerix-B.
    •To evaluate and further characterise the reactogenicity and its kinetics following the administration of GSK Biologicals’ adjuvanted investigational vaccine or of Engerix-B.
    •To evaluate the safety following the administration of GSK Biologicals’ adjuvanted investigational vaccine or of Engerix-B.
    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, 18 and 45 years of age at the time of first study product administration.
    •Written informed consent obtained from the subject.
    •Healthy subjects, in the opinion of the investigator, as established by medical history, clinical examination, and clinical laboratory assessment with no active disease that could interfere with the study endpoints, before entering into the study.
    •Body Mass Index (BMI) between 18.5 and 30 kg/m2.
    •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 first study product administration , and
    -has a negative pregnancy test on the day of placebo administration/ vaccination, and
    -has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study.
    E.4Principal exclusion criteria
    •Known history of HBV infection.
    •Previous vaccination against hepatitis B.
    •Positive for anti-hepatitis B surface (HBs) antibodies, anti-hepatitis B core (HBc) antibodies, HBsAg, HCV antibodies and/or HIV.
    •Any previous administration of vaccine components.
    •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first study product administration , or planned use during the study period.
    •No significant dietary restrictions or life-threatening food allergies.
    •Regular use of non steroidal anti-inflammatory drugs within 1 month prior to first study product administration .
    •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first study product administration. Inhaled and topical steroids are allowed.
    •Planned administration / administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first study product administration and during the entire study period(both Steps), with the exception of the influenza vaccine (pandemic or seasonal) which can be administered > 21 days preceding or > 21 days following each placebo/vaccine administration.
    •Administration of immunoglobulins and/or any blood products within the last 3 months preceding the first study product administration or planned administration during the study period.
    •Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV based on screening evaluations and on medical history and physical examination.
    •History of or current bleeding or coagulation disorder.
    •Any known or clinical signs of anaemia or any clinical condition (including vascular disorder) that would preclude frequent blood drawings.
    •Poor venous access as assessed at screening by the investigator.
    •Blood loss, including blood donation, of more than 300 mL within 90 days before the first study product administration .
    •History of or current autoimmune or other immune-mediated disease.
    •Any haematological or biochemical level out of normal range before entering into the study, as follows:
    -Haemoglobin level < lower normal limit (LNL).
    -Platelet counts out of normal range.
    -Alanine aminotransferase [ALT] > upper normal limit (UNL).
    -Aspartate aminotransferase [AST] > UNL.
    -Creatinine > UNL.
    -c-reactive protein [CRP] > UNL.
    -Creatine phosphokinase [CPK] > UNL without any plausible explanation for this abnormality (such as sport activity).
    In case of haematological and/or biochemical value out of range for parameters mentioned here above, one re-testing of out of range value may be performed.
    •Any acute or chronic, clinically significant disease, as determined by medical history, physical examination or laboratory screening tests.
    •Known or suspected reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
    •Acute disease and/or fever at the time of enrolment.
    -Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
    -Fever is defined as temperature ≥ 37.5°C for oral route.
    •Pregnant or lactating female.
    •Recent history of chronic alcohol consumption and/or drug abuse.
    •Other conditions that the principal investigator judges may interfere with study findings.
    E.5 End points
    E.5.1Primary end point(s)
    Innate/early immune response: Soluble mediators from the innate/early immune response in all subjects (Step 1 and Step 2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day of study product administration (D-30 [step 1 only], D0 [both steps], D30 [step 1 & Group C in step 2], D180 [Group D in step 2 only]) and, during a maximum of 7 day follow-up period post study product administration.
    E.5.2Secondary end point(s)
    -Adaptive response: Classical cellular and humoral immune response to components of the study vaccine.
    -Occurrence of solicited and non-serious unsolicited adverse events (AEs) (Step 1 and 2).
    -Occurrence of any serious adverse event (SAE) (Step 1 and 2).
    -Occurrence of any Potential Immune-Mediated Disease (pIMD) (Step 1 and 2).
    -Occurrence of any new medical condition requiring medical attention (Step 1 and 2).
    -Safety laboratory parameters (Step 1 and 2).
    -Vital signs (Step 1 and 2).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Adaptive response: D0, D44, D60, D180, D210 (Step1) - D0, D44 (GroupC) - D0, D194 (GroupD-Step2)
    Solicited and unsolicited AEs: Day of study product administration (D-30 [step1], D0 and D30 [both Steps], D180 [GroupD-Step 2]) and during a max of 28 day FU period post study product administration
    Occurrence of any SAE & pIMD: Entire study period
    New medical condition requiring medical attention: Entire study period
    Safety laboratory parameters: At D0, D1, D7, D30, D31, D37, D60 (Step1) - D0, D2, D30, D31, D32, D37, D60 (GroupC) - D0, D2, D180, D181, D182, D187, D210 (GroupD-Step2)
    Vital signs: Day of study product administration (D-30 [step1], D0 [both steps], D30 [Step1 & GroupC-Step2] and D180 (GroupD-Step2) and, during a max of 30 day FU period post study product administration
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    This trial will be conducted in 2 steps. Each step will contain 2 parallel arms.
    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 trial4
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days21
    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: 90
    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 state90
    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 Decision2013-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-09-13
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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