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    Summary
    EudraCT Number:2015-005352-10
    Sponsor's Protocol Code Number:E2I34
    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 number2015-005352-10
    A.3Full title of the trial
    Immunogenicity and Safety of the Aventis Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 2, 4 and 6 Months of Age and Followed by a Booster Dose at 18 to 19 Months of Age in Healthy Infants in Thailand. All Infants Receiving Recombinant Hepatitis B Vaccine at 0, 2 and 6 Months of Age.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand.
    A.4.1Sponsor's protocol code numberE2I34
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00255021
    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 INTERNATIONAL
    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 PENTAXIM™
    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//PRP-T combined vaccine
    D.3.4Pharmaceutical form Powder and suspension for 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.IMP: 2
    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 Euvax B™
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PASTEUR SA
    D.2.1.2Country which granted the Marketing AuthorisationThailand
    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 B Vaccine, recombinant
    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 Yes
    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
    Healty volunteers: active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b (such as meningitis, septicaemia, cellulitis, arthritis, epiglottitis, pneumopathy, osteomyelitis)
    E.1.1.1Medical condition in easily understood language
    Protection against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b
    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
    Immunogenicity:
    To assess the seroprotection rates (D, T, polio types 1, 2 and 3, and PRP) and seroconversion rates (PT, FHA) of Aventis Pasteur’s DTacP-IPV//PRP~T combined vaccine, one month after the three-dose primary vaccination.
    To describe the immunogenicity of the study combined vaccine (PENTAXIM™) one month after the three-dose primary vaccination (Visit 4), prior to the booster dose (at Visit 5) and one month after the booster dose (Visit 6).
    To describe the immunogenicity of the recombinant hepatitis B vaccine antigen one month after the three-dose primary vaccination (Visit 4) and approximately 11 to 12 months later (Visit 5).

    Safety:
    To describe the safety after each dose of the study combined vaccine (PENTAXIM™).
    To describe the safety after each study dose of recombinant hepatitis B vaccine
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Aged 53 to 70 days inclusive on the day of inclusion
    2) Born at full term pregnancy (>37 weeks) with a birth weight ≥ 2.5 kg
    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
    5) First dose of Hepatitis B vaccine received within 24 hours of birth
    E.4Principal exclusion criteria
    1) Participation in another clinical trial in the 4 weeks preceding the (first) 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 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.
    7) Mother known as seropositive to HIV or Hepatitis B
    8) Any vaccination in the 5 weeks preceding the first trial vaccination (except BCG)
    9) History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection or Hepatitis B (confirmed either clinically, serologically or microbiologically).
    10) Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection with the trial vaccine or another vaccine.
    11) Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
    12) History of/current seizures
    13) Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity:
    One month after the third dose of study combined vaccine (visit 4)
    - individual antibodies titers : all antibodies
    - anti-Diphtheria antibody titers ≥ 0.01 IU/mL (Seroneutralization)
    - anti-Diphtheria antibody titers ≥ 0.1 IU/mL (Seroneutralization)
    - anti-Tetanus antibody titers ≥ 0.01 IU/mL (ELISA)
    - anti-Tetanus antibody titers ≥ 0.1 IU/mL (ELISA)
    -anti-Polio 1, 2 and 3 antibody titers ≥ 8 (1/dil) (Seroneutralization)
    -anti-PRP antibody titer ≥ 0.15 μg/mL (Farr type RIA)
    -anti-PRP antibody titers ≥ 1.0 μg/mL (Farr type RIA)
    -anti-PT and anti-FHA antibody titers (EU/mL) ≥ 4-fold increase (ELISA)
    -anti-PT and anti-FHA antibody titers (EU/mL) ≥ 2-fold increase (ELISA)
    - anti-PT and anti-FHA antibody titers ≥ 5 EU/mL, ≥ 10 EU/mL and ≥ 25 EU/mL (ELISA)
    - anti-HBs antibody titers ≥ 10 mIU/mL (RIA)
    - individual titers ratios*: for anti-FHA (EU/mL) and anti-PT (EU/mL) antibodies (ELISA).
    Before the booster dose of the study combined vaccine (Visit 5)
    - individual antibody titers: anti-HBs antibodies (mIU/mL) (RIA)
    - anti-HBs antibody titers ≥ 10 mIU/mL (RIA)
    Before (visit 5) and after (visit 6) the booster dose of the study combined vaccine
    - individual antibody titers: all antibodies (except anti-HBs antibodies)
    - anti-PRP antibody titers ≥ 0.15 μg/mL and ≥ 1.0 μg/mL (Farr type RIA)
    - 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 6)
    - anti-PT and anti-FHA antibody titers (EU/mL) ≥ 2- and 4-fold increase (ELISA)
    - individual antibody titers ratio *: anti-FHA (EU/mL) and anti-PT (EU/mL) antibody titers (ELISA).
    *Individual titer ratio: post-primary vaccination / pre-primary vaccination and post-booster dose / pre- booster dose

    Safety:
    The occurrence, time to onset, duration, severity, and seriousness of the solicited (terms pre-listed in the CRF) injection site and systemic reactions between D0 and D7 after each injection:
    The occurrence, nature (MedDRA preferred term), time to onset, duration, severity, relationship to vaccination and seriousness of unsolicited (spontaneously reported) systemic adverse events from vaccination day to day 30.
    The occurrence, nature (MedDRA preferred term), time to onset, duration, severity, and seriousness of unsolicited (spontaneously reported) injection site adverse events from vaccination day to Day 30.
    The occurrence, nature, time to onset, duration, severity, relationship to vaccination of any serious adverse event ( SAE) occurring throughout the trial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Six visits (V) and 4 blood samples (BL) will be performed in all infants.
    A blood samples of 4 ml will be taken at:
    • just before the first dose (BL01-V01),
    • one month after the third dose (BL02-V04),
    • just before the booster dose (BL03-V05), and
    • one month after the booster dose (BL04-V06) of combined vaccine.
    E.5.2Secondary end point(s)
    None
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 186
    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: 186
    F.1.1.5Children (2-11years) No
    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
    Young children (infants & toddlers): 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 186
    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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