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    Summary
    EudraCT Number:2015-005191-18
    Sponsor's Protocol Code Number:HAF78
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-11-19
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-005191-18
    A.3Full title of the trial
    Immunogenicity and Safety of Sanofi Pasteur’s AVAXIM 80U Pediatric Vaccine Administered in Healthy Adolescents, Children and Toddlers in People’s Republic of China Followed by a Booster Dose 6 Months after the Initial Dose Versus HAVRIX 720 Vaccine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose
    A.4.1Sponsor's protocol code numberHAF78
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00483470
    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 SponsorSanofi Pasteur SA
    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 supportSanofi Pasteur SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur SA
    B.5.2Functional name of contact pointFranchise Medical Director
    B.5.3 Address:
    B.5.3.1Street Address2 Avenue Pont Pasteur
    B.5.3.2Town/ cityLyon
    B.5.3.3Post codeF-69367
    B.5.3.4CountryFrance
    B.5.6E-mailRegistryContactUS@sanofipasteur.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 AVAXIM 80U Pediatric
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur SA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 A vaccine
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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.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 HAVRIX 720
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 A vaccine
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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
    Hepatitis A
    E.1.1.1Medical condition in easily understood language
    Hepatitis A
    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
    1) To demonstrate the non-inferiority in terms of seroprotection rate of AVAXIM 80U Pediatric vaccine versus HAVRIX 720 vaccine 1 month after booster vaccination.
    E.2.2Secondary objectives of the trial
    1) To describe the immunogenicity of the study vaccines after booster vaccination in both vaccine groups.
    2) To describe the safety after each injection of the study vaccines.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria to be checked at the screening visit (SC):
    1) Toddlers, children and adolescents:
    Sub-Group 1: from 12 months to 3 years of age on the day of inclusion
    Sub-Group 2: from 4 to 6 years of age on the day of inclusion
    Sub-Group 3: from 7 to 9 years of age on the day of inclusion
    Sub-Group 4: from 10 to 12 years of age on the day of inclusion
    Sub-Group 5: from 13 to 15 years of age on the day of inclusion

    2) Screening informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only)

    Inclusion criteria to be checked at the inclusion visit (V01):
    1) Toddlers, children and adolescents:
    Sub-Group 1: from 12 months to 3 years of age on the day of inclusion
    Sub-Group 2: from 4 to 6 years of age on the day of inclusion
    Sub-Group 3: from 7 to 9 years of age on the day of inclusion
    Sub-Group 4: from 10 to 12 years of age on the day of inclusion
    Sub-Group 5: from 13 to 15 years of age on the day of inclusion

    2) Inclusion informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only)
    3) Able to attend all scheduled visits and to comply with all trial procedures
    4) Subject anti-HAV seronegative (IgG) according to the screening results (assay performed with local kit)
    5) Subject HBsAg seronegative and ALT <40 IU/l according to the screening results
    E.4Principal exclusion criteria
    Exclusion criteria to be checked at the inclusion visit (V01):
    1) Participation in another clinical trial in the 4 weeks preceding trial vaccination
    2) Planned participation in another clinical trial during the present trial period
    3) Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
    4) Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances
    5) Chronic illness at a stage that could interfere with trial conduct or completion
    6) Blood or blood-derived products received in the past 3 months
    7) Any vaccination in the 4 weeks preceding the trial vaccination
    8) Any vaccination planned in the 4 weeks following the trial vaccination
    9) History of hepatitis A infection (confirmed either clinically or serologically )
    10) Previous vaccination against hepatitis A with the trial vaccine or another hepatitis A vaccine
    11) Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
    12) History of /current seizures
    13) Clinical or serological evidence of systemic illness including Hepatitis C and HIV
    14) Febrile (axillary temperature ≥ 37.1°C) or acute illness
    E.5 End points
    E.5.1Primary end point(s)
    1) To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month post-vaccination
    E.5.2Secondary end point(s)
    Immunogenicity:
    1) Individual anti-Hepatitis A antibody titers

    Safety:
    1) The occurrence, nature (MedDRA preferred term), time to onset, duration, severity, relationship to vaccination of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination.
    2) The occurrence, time to onset, number of days of occurrence and severity of the solicited (terms pre-listed in the Case Report Form [CRF]) injection site and systemic reactions between D0 and D7 after each injection.
    3) The occurrence, nature (MedDRA preferred term), time to onset, duration, severity and relationship to vaccination of unsolicited (spontaneously reported) AEs from vaccination day to next study visit.
    4) The occurrence, nature (MedDRA preferred term), time to onset, duration, relationship to vaccination, outcome, seriousness of any Serious Adverse Event (SAE) occurring throughout the trial.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity:
    1) One month after booster vaccination in both groups (at V04/D210):

    Safety:
    1) 30 minutes after each vaccination
    2) Day 0 and Day 7 after each injection
    3) Vaccination day to next study visit
    4) Throughout the trial
    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 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 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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Hepatitis A vaccine
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    China
    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.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 720
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 78
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 376
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 266
    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 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 720
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: China
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