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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2011-004458-25
    Sponsor's Protocol Code Number:RVX01C
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2011-10-11
    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 ConcernedFrance - ANSM
    A.2EudraCT number2011-004458-25
    A.3Full title of the trial
    Antibody persistence in 11 to 13-year-old children previously vaccinated at 6 years old with either REVAXIS or DT Polio, and immune response to a booster dose of TETRAVAC-ACELLULAIRE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Persistance des anticorps chez des enfants de 11 à 13 ans vaccinés à 6 ans avec REVAXIS® ou DT Polio®, et réponse immunitaires après une dose de rappel de TETRAVAC-ACELLULAIRE®.
    A.3.2Name or abbreviated title of the trial where available
    Antibody persistence to REVAXIS or DT Polio and Immune response to TETRAVAC-ACELLULAIRE
    A.4.1Sponsor's protocol code numberRVX01C
    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 MSD
    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 MSD
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur MSD
    B.5.2Functional name of contact pointClinical trial information
    B.5.3 Address:
    B.5.3.1Street Address8, rue Jonas Salk
    B.5.3.2Town/ cityLyon Cedex 07
    B.5.3.3Post code69367
    B.5.3.4CountryFrance
    B.5.4Telephone number33437284060
    B.5.5Fax number33437284451
    B.5.6E-mailctran@spmsd.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 TETRAVAC-ACELLULAIRE
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PASTEUR MSD SNC
    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 nameTETRAVAC-ACELLULAIRE
    D.3.2Product code 094
    D.3.4Pharmaceutical form 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 INNDIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT) AND POLIOMYELITIS (INACTIVATED) VACCINE (ADSORBED)
    D.3.9.3Other descriptive nameDIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT) AND POLIOMYELITIS (INACTIVATED) VACCINE (ADSORBED)
    D.3.9.4EV Substance CodeSUB11918MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    Persistence of antibody against diphtheria, tetanus and poliomyelitis in 11 to 13-year-old children who received either REVAXIS or DT Polio at 6 year of age, and immune response to TETRAVAC-ACELLULAIRE
    E.1.1.1Medical condition in easily understood language
    Protection against Diphtheria, Tetanus, Pertussis and Poliomyelitis
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10054175
    E.1.2Term Polio immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10054129
    E.1.2Term Diphtheria immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10069577
    E.1.2Term Pertussis immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10054131
    E.1.2Term Tetanus immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 in 11 to 13-year-old children who received one dose of either REVAXIS or DT Polio at 6 years of age the antibody persistence in terms of proportions of subjects with antibody concentrations ≥0.01 IU/mL against diphtheria and tetanus, and antibody titres ≥8 (1/dilution) against poliovirus types 1, 2 and 3,
    To describe one month after a booster dose of TETRAVAC-ACELLULAIRE when given to 11 to 13-year-old children who received one dose of either REVAXIS or DT Polio at 6 years of age the immune responses in terms of proportions of subjects with antibody concentrations ≥0.1 IU/mL against diphtheria and tetanus, and antibody titres ≥8 (1/dilution) against poliovirus types 1, 2 and 3.
    E.2.2Secondary objectives of the trial
    Secondary immunogenicity objectives:
    To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens in 11 to 13-year-old children who received one dose of either REVAXIS or DT Polio at 6 years of age.
    To describe other parameters of the immune responses to diphtheria, tetanus, pertussis and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE when given to 11 to 13-year-old children who received one dose of either REVAXIS or DT Polio at 6 years of age.
    Secondary safety objective:
    To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE when given to 11 to 13-year-old children who received one dose of either REVAXIS or DT Polio at 6 years of age.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy child of either gender 11 to 13 years of age and vaccinated in Study F05-TdI-301 with either REVAXIS or DT Polio at approximately 6 years of age,
    Consent form signed by both parents, or by the legal guardian, properly informed about the study,
    Assent form signed by the child,
    Affiliated to a health social security system.
    E.4Principal exclusion criteria
    Immunization against diphtheria, tetanus, pertussis and/or poliomyelitis beyond Study F05-TdI-301,
    Previous clinical or bacteriological diagnosis of diphtheria, tetanus, pertussis or poliomyelitis,
    Immune impairment or humoral/cellular deficiency, neoplasic disease or depressed immunity,
    Receipt of any chemotherapy agents to treat cancer received within 6 months prior to vaccination
    Receipt of serum immune globulin or any other blood-derived product within 3 months prior to vaccination
    Receipt of immunomodulator therapy within 6 weeks prior to vaccination
    Receipt of daily -or on alternate days- systemic corticosteroids at a dose ≥20 mg/day of prednisone (or equivalent) for ≥14 days within 4 weeks prior to vaccination
    Receipt of any live non-study vaccine within 28 days or of any inactivated non-study vaccine within 14 days prior to vaccination or with a vaccination planned during the whole study period,
    Known true hypersensitivity to at least one of the components of TETRAVAC-ACELLULAIRE, to glutaraldehyde, neomycin, streptomycin and polymyxin B, to pertussis, vaccines (acellular or whole cell pertussis), or to a vaccine containing the same substances,
    Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
    Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection,
    Any medical condition that, in the opinion of the investigator, could interfere with the evaluation of the study objectives,
    Child who participated in another clinical study within 28 days prior to vaccination or would participate in another clinical study during the whole study period,
    Acute severe febrile illness and/or body temperature >=38.0°C within 72 hours prior to vaccination.
    E.5 End points
    E.5.1Primary end point(s)
    Antibody persistence
    Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL,
    Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL,
    Proportion of subjects with an anti-poliovirus type 1 (IPV1) titre ≥8 (1/dilution),
    Proportion of subjects with an anti-poliovirus type 2 (IPV2) titre ≥8 (1/dilution),
    Proportion of subjects with an anti-poliovirus type 3 (IPV3) titre ≥8 (1/dilution).

    Post-booster immune response
    Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL,
    Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL,
    Proportion of subjects with an anti-IPV1 titre ≥8 (1/dilution),
    Proportion of subjects with an anti-IPV2 titre ≥8 (1/dilution),
    Proportion of subjects with an anti-IPV3 titre ≥8 (1/dilution).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before vaccination at V1
    E.5.2Secondary end point(s)
    Antibody persistence
    Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL,
    Anti-diphtheria Geometric Mean Concentration (GMC),
    Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL,
    Anti-tetanus GMC,
    Anti-IPV1, anti-IPV2 and anti-IPV3 Geometric Mean Titres (GMT).

    Post-booster immune response
    Proportion of subjects with an anti-diphtheria concentration ≥1.0 IU/mL,
    Anti-diphtheria GMC,
    Anti-diphtheria Geometric Mean of individual Concentrations Ratio (GMCR),
    Proportion of subjects with an anti-tetanus concentration ≥1.0 IU/mL,
    Anti-tetanus GMC,
    Anti-tetanus GMCR,
    Anti-IPV1, anti-IPV2 and anti-IPV3 GMT,
    Anti-IPV1, anti-IPV2 and anti-IPV3 Geometric Mean of individual Titres Ratio (GMTR).
    E.5.2.1Timepoint(s) of evaluation of this end point
    28-35 days after vaccination (V2)
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 concerned45
    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
    End of data collection including availability of serology results
    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 months10
    E.8.9.1In the Member State concerned days0
    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: 476
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 300
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 176
    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.4.1In the member state476
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 476
    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 Decision2011-10-18
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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