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    Summary
    EudraCT Number:2007-005168-29
    Sponsor's Protocol Code Number:HXV01C
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-11
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-005168-29
    A.3Full title of the trial
    An Open-label, randomised, controlled, multi-centre study of the immunogenicity and safety of a booster dose of two different Hepatitis B vaccines to explore the anamnestic immune response in healthy 4 to 7 year-old children previously vaccinated at about 3, 5 and 11 to 13 months of age with either HEXAVAC or INFANRIX-HEXA
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberHXV01C
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PASTEUR MSD SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical 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, purified antigen
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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 SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical 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, purified antigen
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    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
    anamnestic immune response in healthy 4 to 7 year-old children previously vaccinated at about 3, 5 and 11 to 13 months of age
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054130
    E.1.2Term Hepatitis B immunisation
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Immunogenicity To describe in subjects vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre &#8805;10 mIU/mL (i.e. seroprotection rate) 1 month after a booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO 5 &#956;g or ENGERIX-B 10 &#956;g.
    E.2.2Secondary objectives of the trial
    Immunogenicity To describe in subjects vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX-HEXA during the two first years of life: - The percentage of subjects with anti-HBs antibody titres &#8805;100 mIU/mL at 1 month post-booster dose (4th dose of a Hepatitis B vaccine) of each of either HBVAXPRO 5 µg or ENGERIX-B 10 µg. - The anti-HBs antibody titres at each time-point. - The percentage of subjects with anti-HBs antibody titres &#8805;10 mIU/mL and &#8805;100 mIU/mL and the anti-HBs antibody titres at 1 month post-booster dose (4th dose of a Hepatitis B vaccine) of either HBVAXPRO 5 µg or ENGERIX-B 10 µg according to the pre-booster anti-HBs antibody titres. Safety To describe the safety profile of each of both HBVAXPRO 5 µg and ENGERIX-B 10 µg when administered as a booster dose (4th dose of a Hepatitis B vaccine
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy child of either gender, 2. Child of 4 to 7 years of age (from the first day of the 4th birthday to one day prior to the 8th birthday) 3. Groups 1A and 1B: Child vaccinated with 2 doses of HEXAVAC during the first 6 months of life and with a 3rd dose of HEXAVAC during the second year of life (documented vaccination history), or Groups 2A and 2B: Child vaccinated with 2 doses of INFANRIX-HEXA during the first 6 months of life and with a 3rd dose of INFANRIX-HEXA during the second year of life (documented vaccination history), 4. Informed consent form signed by the parent(s) or by the legal representative according to the local regulations. 5. Parent(s) or legal representative able to attend all scheduled visits with the subject and to understand and comply with the study procedures (i.e. able to read and write).
    E.4Principal exclusion criteria
    1- Any recent (equal or less than 3 days) history of febrile illness (rectal temperature equal or greater than 38.0C or oral temperature &#8805;37.5C), 2- Receipt of more than 3 doses of any Hepatitis B containing vaccine, either alone or in any combination, 3- History of clinical or serological-confirmed diagnosis of infection due to hepatitis B, 4- History or current close contact with known carriers of hepatitis B virus, 5- Prior known sensitivity/allergy to any component of the study vaccines, 6- Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems, 7- Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection, 8- Any immune impairment or humoral/cellular deficiency or depressed immunity, 9- Any recent (eual or less than 30 days) long-term (equal or more than 14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses (more or qgual to 20mg/day) or scheduled administration through Visit 2, 10- Any receipt (eual or less than 3 months) of immune globulin or blood-derived product, or scheduled administration through Visit 2, 11- Any recent (equal or less than 14 days) receipt of an inactivated vaccine or scheduled administration through Visit 2, 12- Any recent (equal or less than 28 days) receipt of a live vaccine or scheduled administration through Visit 2 13- Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, 14- Subject that, in the investigator’s opinion, is likely to be lost to follow-up or to be poorly compliant with the study requirements, 15- Planned participation in another clinical study during the present study period. Second part of the study only: Investigators are recommended to defer/reschedule vaccination if any of the following conditions is true: 1. Febrile illness (rectal temperature equal or greater than 38.0C or oral temperature &#8805;37.5C) within 3 days prior to vaccination, 2. Current immunosuppressive therapy (including systemic corticosteroids given daily or on alternate days at equal or more than 20 mg/day prednisone equivalent during 14 days or more in the previous 30 days) 3. Receipt of immunoglobulins or blood-derived products within the previous 3 months 4. Receipt of an inactivated vaccine within the previous 14 days 5. Receipt of a live vaccine within the past 28 days.
    E.5 End points
    E.5.1Primary end point(s)
    This study is a descriptive study. The data will be summarised and no particular formal hypothesis will be tested.
    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 Yes
    E.8.1.1Randomised Yes
    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) Yes
    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 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
    ultima visita dell'ultimo soggetto inserito nella sperimentazione
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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) No
    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 Information not present in EudraCT
    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
    consenso verra` dato dai genitori o dal legale rappresentante
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state668
    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)
    nessuno
    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 Decision2008-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
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