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    The EU Clinical Trials Register currently displays   38179   clinical trials with a EudraCT protocol, of which   6271   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-003500-23
    Sponsor's Protocol Code Number:Td517
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-01-13
    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 number2015-003500-23
    A.3Full title of the trial
    Safety and Immunogenicity of Tdap Vaccine Compared to DTaP vaccine
    as Fifth Dose Booster in Children 4 to 6 Years of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Immunogenicity of Tdap Vaccine Compared to DTaP vaccine
    as Fifth Dose Booster in Children 4 to 6 Years of Age
    A.4.1Sponsor's protocol code numberTd517
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00467519
    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 INC.
    B.1.3.4CountryUnited States
    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
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportSANOFI PASTEUR
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI PASTEUR
    B.5.2Functional name of contact pointOladayo OYELOLA
    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-mailoladayo.oyelola@sanofipasteur.com
    D. IMP Identification
    D.IMP: 1
    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 Adacel, Covaxis, Triaxis
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PASTEUR, SANOFI
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
    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
    Active immunization against tetanus, diphtheria and pertussis
    E.1.1.1Medical condition in easily understood language
    Protection against tetanus, diphtheria and pertussis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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 18.1
    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 18.1
    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
    1) To compare the immune responses of Tdap to DTaP vaccine when
    each is administered as a 5th dose to DAPTACEL- or Pentacel-primed
    subjects and given concurrently, but in a separate arm from
    poliomyelitis, measles, mumps, rubella (MMR) and varicella vaccines to
    children aged 4 to 6 years, as measured by seroprotection rates (³ 0.1
    IU/mL), serothreshold rates (³ 1.0 IU/mL) and booster response rates
    for diphtheria and tetanus.

    2) To compare immune responses of Tdap to DTaP vaccine when
    administered as a 5th dose to DAPTACEL- or Pentacel-primed subjects
    and given concurrently, but in a separate arm from poliomyelitis,
    measles, mumps, rubella (MMR) and varicella vaccines to children aged
    4 to 6 years, as measured by booster response rates and GMTs for
    pertussis antigens (PT, FHA, PRN and FIM).
    E.2.2Secondary objectives of the trial
    Immunogenicity
    To compare immune responses of Tdap to DTaP vaccine when administered as a 5th dose and given concurrently; but in a separate arm from poliomyelitis, MMR, and varicella vaccines to children aged 4 to 6 years, as measured by 4-fold
    rise rates (post-/pre-vaccination ≥ 4) for pertussis antigens (PT, FHA, PRN, and FIM).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Healthy, as determined by medical history and physical examination.
    2) Aged 4 to 6 (< 7) years at the time of study vaccination on Day 0.
    3) Signed and dated informed consent form that has been approved by the Institutional Review Board (IRB) by the parent or legally authorized representative.
    4) Signed and dated informed assent form from the subject if required by the IRB.
    5) Able to attend scheduled visits at Visit 1 and Visit 2 and able to comply with all trial procedures. Subjects will be invited to participate in the long-term immunogenicity follow-up study but a commitment to participate in the long-term is not required as an inclusion criterion.
    6) Documented vaccination history of 4 previous doses of DAPTACEL (consisting of 3 infant doses in the first year of life and a 4th dose in the 2nd year of life) or 4 previous doses of Pentacel and Prevnar®.
    E.4Principal exclusion criteria
    1) Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
    2) Planned participation in another clinical trial during the original trial period.
    3) Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
    4) Systemic hypersensitivity to any of the vaccine components or history of 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 3 months.
    7) Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (with the exception of the annual influenza vaccine).
    8) History of diphtheria, tetanus or pertussis infection (confirmed either serologically or microbiologically).
    9)Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
    E.5 End points
    E.5.1Primary end point(s)
    1) For diphtheria and tetanus antibodies, seroprotection rates, serothreshold rates and booster response rates will be assessed as follows:
    - Percent of subjects with anti-diphtheria and anti-tetanus antibody concentrations pre- (Day 0), post-vaccination (Day 30) ³ 0.1 IU/mL (for seroprotection) and ³ 1.0 IU/mL (for serothreshold)
    - Percent of subjects demonstrating a booster response postvaccination (Day 30) for anti-diphtheria and anti-tetanus antibody concentrations. The criterion for demonstrating a booster response is as follows:
    - Subjects whose pre-vaccination antibody concentrations are < 0.1 IU/mL will demonstrate the booster response if they have postvaccination levels ≥ 0.4 IU/mL
    - Subjects whose pre-vaccination antibody concentrations are ≥ 0.1 to < 2 IU/mL will demonstrate the booster response if they have a 4-fold rise rate (i.e., post-/pre-vaccination ≥ 4)
    - Subjects whose pre-vaccination antibody concentrations are ≥ 2.0 IU/mL will demonstrate the booster response if they have a 2-fold response (i.e., post-/pre-vaccination ≥ 2)
    2) For each anti-pertussis antibody (PT, FHA, PRN and FIM) the percent of subjects demonstrating the booster response and the GMTs will be assessed as follows:
    - The booster response rate partially adjusts for individual and population differences in pre-vaccination antibody concentrations. The criterion for demonstrating a booster response is as follows:
    - Subjects whose pre-vaccination antibody concentrations are less than the Lower Limit of Quantitation (< LLOQ) for each anti-pertussis (PT, FHA, PRN and FIM) antibody, will demonstrate the booster response if they have post-vaccination levels ≥ 4xLLOQ
    - Subjects whose pre-vaccination antibody concentrations are ≥ LLOQ but < 4xLLOQ, will demonstrate the booster response if they have a 4-fold rise rate (i.e., post-/pre-vaccination ≥ 4)
    - Subjects whose pre-vaccination antibody concentrations are ≥ 4xLLOQ, will demonstrate the booster response if they have a 2-fold response (i.e., post-/pre-vaccination ≥ 2) Pre- and post-vaccination GMTs will be assesed.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 vaccination visit. Each subject received 3/4* injections
    Day 0 Visit 1 Group A:Tdap (left arm)+polio, MMR, & varicella vaccines (right arm) Day 0; Visit 1 Group B:DTaP (left arm; +polio, MMR, & varicella vaccines (right arm) Day 0; Visit 1 MMR & varicella vaccines were given either as 1 dose MMRV or as 2 separate doses 2 blood samples (BL1&BL2) totaling approx. 10 mL were collected from each subject: BL1 (5mL) collected prior to Visit 1 vaccination (Day 0). BL2 (5mL) collected on Visit 2 (Day 30). Each subject was followed for safety up to 180 days after vaccination initiated at 3, 8, 30, & 180 days after vaccination. Study duration was approx. 6 months. Subjects in the LTI follow-up, up to 2 blood samples (BL3 & BL4) collected from each subject up to 5 yrs after Visit 1 vaccination.
    E.5.2Secondary end point(s)
    Immunogenicity
    Antibody concentrations against pertussis antigens (PT, FHA, PRN and FIM) as measured by 4-fold rise rates (i.e., post-/pre-vaccination ≥ 4) were assessed
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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.8.2.4Number 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
    Canada
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years2
    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.1.1Number of subjects for this age range: 1045
    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: 1045
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Young children: Informed consent is documented by means of a written, signed, and dated informed consent form (ICF) by the subjects parent(s)/legally authorized representative for subjects under 12 years old.
    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 1045
    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: United States
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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