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    Summary
    EudraCT Number:2015-005403-87
    Sponsor's Protocol Code Number:E2I57
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-12-04
    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 number2015-005403-87
    A.3Full title of the trial
    Immunogenicity and Safety of the sanofi pasteur’s DTacP-IPV Combined Vaccine (TETRAXIM™) given as a booster dose at 4 to 6 years of life in children previously vaccinated with PENTAXIM™ in the study E2I34
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age.
    A.4.1Sponsor's protocol code numberE2I57
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01031303
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1112-2680
    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 pointMEDICAL PRODUCT LEADER
    B.5.3 Address:
    B.5.3.1Street Address1 Discovery Drive
    B.5.3.2Town/ citySWIFTWATER, PA
    B.5.3.3Post code18370
    B.5.3.4CountryUnited States
    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 TETRAXIM™
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PASTEUR SA
    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 nameDTacP-IPV combined vaccine
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 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
    Healthy volunteers: indicated for primary vaccination in infants for active immunization against diphtheria, tetanus, pertussis and poliomyelitis.
    E.1.1.1Medical condition in easily understood language
    Protection against diphtheria, tetanus, pertussis and poliomyelitis.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10036897
    E.1.2Term Prophylactic vaccination
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level HLGT
    E.1.2Classification code 10043413
    E.1.2Term Therapeutic procedures and supportive care NEC
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10021430
    E.1.2Term Immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level HLT
    E.1.2Classification code 10021431
    E.1.2Term Immunisations
    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 assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to acellular Pertussis antigens (PT, FHA) of sanofi pasteur’s DTacP-IPV (Tetraxim™) vaccine, one month after the booster dose given at 4 to 6 years of age.
    E.2.2Secondary objectives of the trial
    Immunogenicity:
    To describe the antibody persistence in terms of anti-pertussis antibody levels (anti-PT, and -FHA) and in terms of seroprotection rates and GMTs for Diphtheria, Tetanus, and Poliovirus types 1, 2 and 3, just before administration of the booster dose (at Visit 1) in all subjects at 4-6 years of age.
    To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/ vaccine response rates to acellular Pertussis antigens (PT, FHA) of sanofi pasteur’s DTacP-IPV (Tetraxim™) vaccine, one month after administration of the booster dose given at 4 to 6 years of age according to the secondary endpoints below.

    Safety:
    To describe the safety after the booster dose of the study vaccine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    An individual must fulfill all of the following criteria in order to be eligible for trial
    enrollment:
    1) Aged 4-6 years inclusive on the day of inclusion
    2) Child having completed the three-dose vaccination and the booster
    vaccination with DTacP-IPV//PRP~T combined vaccine (Pentaxim™) of the study E2I34
    3) Informed consent form signed by the parent(s) or other legal representative
    4) Able to attend all scheduled visits and to comply with all trial procedures
    E.4Principal exclusion criteria
    An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
    1) Participation in another clinical trial in the 4 weeks preceding the trial inclusion
    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 vaccine components or history of a life-threatening reaction to the trial vaccine 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 or current or planned administration during the trial (including immunoglobulins)
    7) Any vaccination in the 4 weeks preceding the trial vaccination
    8) History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
    9) Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
    10) Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases infection with the trial vaccine or another vaccine after completion of previous study E2I34
    11) Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
    12) History of/current major neurological diseases or seizures
    13) Febrile illness (temperature ≥ 38°C) or acute illness on the day of inclusion.
    14) Serious or severe reaction after a previous dose of any vaccine containing pertussis antigen, such as
    • encephalopathy (with or without convulsions) in the 7days following previous administration of a pertussis containing vaccine,
    • temperature more than 39.5°C within 48 hours following vaccine injection, not due to another identifiable cause
    • inconsolable crying equal or more than 3 hours within 48 hours following vaccine injection,
    • hypotonic hyporesponsive episode within 48 hours following vaccine injection,
    • seizures with or without fever within 3 days following vaccine injection.
    E.5 End points
    E.5.1Primary end point(s)
    One month after administration of the booster dose of the study combined vaccine (Visit 2):
    • anti-Diphtheria antibody titers ≥ 0.1 IU/mL (Seroneutralization)
    • anti-Tetanus antibody titers ≥ 0.1 IU/mL (ELISA)
    • anti-Polio 1, 2 and 3 antibody titers ≥ 8 (1/dil) (Seroneutralization)
    • anti-PT and anti-FHA antibody titers (EU/mL) ≥ 4-fold increase
    (ELISA) from baseline (V01) to V02
    E.5.1.1Timepoint(s) of evaluation of this end point
    Two visits (V) and 2 blood samples (BL) will be performed in all infants included. Subjects will receive the study vaccine [sanofi pasteur’s DTacP-IPV vaccine (TETRAXIM™)] at 4 to 6 years of age (at visit 1).
    For antibody determinations, a blood sample of approximately 5 mL will be taken in
    all subjects:
    • just before the booster dose (BL1-V01, at 4-6 years of age),
    • one month after the booster dose (BL2-V02)
    E.5.2Secondary end point(s)
    Immunogenicity:
    Just before the booster dose of the study combined vaccine (Visit 1):
    • individual antibodies titers for all antigens
    • anti-Diphtheria antibody titers ≥ 0.01 IU/mL and ≥ 0.1 IU/mL (Seroneutralization)
    • anti-Tetanus antibody titers ≥ 0.01 IU/mL and ≥ 0.1 IU/mL (ELISA)
    • anti-Polio 1, 2 and 3 antibody titers ≥ 8 (1/dil) (Seroneutralization)
    • anti-PT and anti-FHA antibody titers ≥ 5 EU/mL, ≥ 10 EU/mL and ≥ 25 EU/mL (ELISA)

    One month after the booster dose of the study combined vaccine (Visit 2):
    • individual antibodies titers for all antigens
    • anti-Diphtheria antibody titers ≥ 0.01 IU/mL (Seroneutralization)
    • anti-Tetanus antibody titers ≥ 0.01 IU/mL (ELISA)
    • anti-PT and anti-FHA antibody titers (EU/mL) ≥ 2-fold increase (ELISA) from baseline (V01) to V02
    • anti-PT and anti-FHA antibody titers ≥ 5 EU/mL, ≥ 10 EU/mL and ≥ 25 EU/mL (ELISA)
    • individual titers ratios * : all antibodies
    *post-/pre- vaccination titers.

    Safety
    The endpoints for the safety evaluation are:
    1) Occurrence, intensity, and relationship to vaccination of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after vaccination
    2) Occurrence, time to onset, number of days of occurrence and intensity of solicited (prelisted in the subject’s diary card and CRF) injection site and systemic reactions occurring up to 7 days after vaccination.
    3) Occurrence, nature (MedDRA preferred term), duration, maximum intensity and relationship to vaccination (for systemic AEs only) of unsolicited
    E.5.2.1Timepoint(s) of evaluation of this end point
    Two visits (V) and 2 blood samples (BL) will be performed in all infants included. Subjects will receive the study vaccine [sanofi pasteur’s DTacP-IPV vaccine (TETRAXIM™)] at 4 to 6 years of age (at visit 1).
    For antibody determinations, a blood sample of approximately 5 mL will be taken in
    all subjects:
    • just before the booster dose (BL1-V01, at 4-6 years of age),
    • one month after the booster dose (BL2-V02)
    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 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) 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 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 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
    Thailand
    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 years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days30
    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: 167
    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.1.1.5.1Number of subjects for this age range: 167
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children (4 - 6 years old): Informed consent form signed by the parent(s) or other legal representative
    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 167
    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: Thailand
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