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    Summary
    EudraCT Number:2009-016721-33
    Sponsor's Protocol Code Number:rHB01C
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-27
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2009-016721-33
    A.3Full title of the trial
    A Study to Estimate the Immune Response Following a Challenge Dose in Adults (≥ 50 years old) Vaccinated With a Primary Series of an Hepatitis B Vaccine
    A.4.1Sponsor's protocol code numberrHB01C
    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 SponsorSanofi Pasteur MSD S.N.C
    B.1.3.4CountryFrance
    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 HBVaxPRO previously known as Recombivax HB
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameHBVaxPRO
    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
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 0
    D.3.9.3Other descriptive nameHEPATITIS B VACCINE
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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) 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
    Healthy subjects, active immunisation against Hepatitis B
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10019731
    E.1.2Term Hepatitis B
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe the Seroprotection rate (SPR) at least 2 years following completion of a primary series of modified process RECOMBIVAX HB™ ( HBVaxPRO) and 1 month following a challenge dose of modified process RECOMBIVAX HB™

    To describe the Seroprotection rate (SPR) at least 2 years following completion of a primary series of ENGERIX-B™ and 1 month following a challenge dose of modified process RECOMBIVAX HB™.
    E.2.2Secondary objectives of the trial
    To describe the Geometric Mean Titer (GMT) at least 2 years following completion of a primary series of modified process RECOMBIVAX HB™ and 1 month following a challenge dose of modified process RECOMBIVAX HB™.

    To describe the Geometric Mean Titer (GMT) at least 2 years following completion of a primary series of ENGERIX-B™ and 1 month following a challenge dose of modified process RECOMBIVAX HB™.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. In general good health based on a medical history taken on Day 1 prior to receiving the study vaccine injection.

    2. Received 3 doses of either modified process RECOMBIVAX HB™ or ENGERIX-BTM as per protocol for study V232-059 at least 2 years prior to enrollment in this study.
    E.4Principal exclusion criteria
    1. Known history of previous hepatitis B infection.
    2. History of vaccination with any hepatitis B vaccine beyond what was administered in study V232-059.
    3. History of febrile illness (oral temperature ≥37.8ºC or ≥100.0ºF) within 72 hours prior to study vaccine injection.
    4. Known or suspected hypersensitivity to any component of modified process RECOMBIVAX HB™ (e.g., aluminum, yeast).
    5. Receipt of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product within 3 months prior to study vaccine injection and until Visit 2
    6. Receipt of any licensed inactivated or recombinant vaccine within 14 days prior to study vaccine injection and until Visit 2
    7. Receipt of any licensed live-virus vaccine within 30 days prior to study vaccine injection and until Visit 2.
    8. Receipt of any investigational drug or other investigational vaccine within 3 months prior to study vaccine injection and until Visit 2.
    9. Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids or chemotherapeutic agents). Subjects on systemic corticosteroids should be excluded if they received within 4 weeks prior to study entry, are receiving, or are expected to receive prior to Visit 2 systemic corticosteroid doses >5 mg prednisone (or equivalent) daily for >2 weeks. The exclusion does not apply to topical and inhaled steroids.
    10. Known or suspected immune dysfunction that is caused by a medical condition, or other cause. Examples of such conditions include: congenital immune deficiency, human immunodeficiency virus infection, transplantations, leukemia, lymphoma, Hodgkin’s’ disease, multiple myeloma/MGUS, or generalize malignancy. Subjects with a history of cancer who have been cancer free since their participation in the original V232-059 study will be eligible for enrollment.
    11. Pregnant women and nursing mothers. A urine pregnancy test will be administered to women of childbearing potential prior to vaccination. For the purposes of this protocol, women of non-childbearing potential are defined as having no menses for one year, post-hysterectomy, post-bilateral tubal ligation, or post-bilateral oophorectomy.
    12. Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
    E.5 End points
    E.5.1Primary end point(s)
    The primary purpose of this study is to estimate the SPR pre-challenge (i.e., 2 year persistence) and again at 1 month after vaccination. Within groups two-sided 95% CI will be provided for SPR calculated on immunogenicity criteria based on the method of Collett.
    Data with respect to the percentage of subjects with any detectable anti-HBs titer and an anti-HBs titer ≥100 mIU/mL as well as the GMT will be descriptively summarized for each group. Confidence intervals for the percentage of subjects greater than each cut-off will be calculated as above. The confidence interval for the GMTs will be based on the natural log-transformed titers and the t-distribution. Data will be summarized pre-challenge using the same methodology.
    Two-hundred and ninety-six (296) subjects completed V232-059 on a per protocol basis. Of these 152 received modified process RECOMBIVAX HB™ and 144 received ENGERIX-B™. Of the 296 subjects, it is estimated that at least 50% will re-enroll and complete this extension study after at least 2 years of time has lapsed following the initial receipt of the primary vaccination series. Therefore, the study is expected to yield at least 75 evaluable subjects per group. This study is an estimation study with a clinical assumption that the true SPR in subjects receiving a single challenge dose of modified process RECOMBIVAX HB™ will be 50%; this is consistent with the overall lower immune responsiveness seen with increasing age. Therefore, this sample size will have the ability to detect a half-width of the confidence interval of approximately 13 percentage points for the SPR for each group.
    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 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Refer to protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months5
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 133
    F.4.2.2In the whole clinical trial 296
    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)
    Not applicable
    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 Decision2010-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-04-12
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