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    Summary
    EudraCT Number:2015-005842-69
    Sponsor's Protocol Code Number:Td526
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-01-26
    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 number2015-005842-69
    A.3Full title of the trial
    Immune Responses in Adults to Revaccination with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) 10 Years After a Previous Dose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose
    A.4.1Sponsor's protocol code numberTd526
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00712959
    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 Limited
    B.1.3.4CountryCanada
    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 Limited
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportSanofi Pasteur
    B.4.2CountryUnited States
    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 code18730
    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 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 No
    D.2.1.1.1Trade name Adacel, Covaxis, Triaxis
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PASTEUR SA
    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] - Virus Diseases [C02]
    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 diphtheria and tetanus seroprotection rates in Group 1 and Group 2 approximately one month post Tdap-vaccination

    2) To compare the pertussis antibody geometric mean concentrations (GMCs) in
    Group 1 and Group 2 approximately one month post Tdap-vaccination
    E.2.2Secondary objectives of the trial
    Not applicable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Group 1 and Group 2
    1) For Group 1: received Tdap or Tdap-IPV vaccine in study TD9707 or TD9805.
    For Group 2: never previously received Tdap vaccine and has not received any tetanus-, diphtheria-, or pertussis-containing vaccine in the past 10 years

    2) Signed Institutional Review Board (IRB)-approved informed consent form

    3) Able to attend all scheduled visits and to comply with all trial procedures

    4) For a woman, a negative urine pregnancy test and the use of effective method(s) of contraception or the inability to become pregnant

    Group 3
    1) Participated in TD9707* or TD9805 but does not meet inclusion/exclusion criteria for Group 1, or willing to undergo phlebotomy but not willing to receive Tdap (ADACEL) vaccine

    2) Signed Institutional Review Board (IRB)-approved informed consent form

    * Past TD9707 study subjects will qualify for this group, if they were originally enrolled at the two study centers that participated in the 3- and 5-year long-term immunogenicity follow-ups.
    E.4Principal exclusion criteria
    An individual fulfilling any of the following criteria is to be excluded from trial enrollment:

    Group 1 and Group 2
    1) Any condition listed as a contraindication in the ADACEL Canadian product monograph

    2) Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine

    3) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator

    4) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic (injected or oral) corticosteroid therapy. Individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than 1 course within the last 2 weeks prior to enrollment

    5) Febrile illness (temperature ≥ 37.5°C [99.5°F]) at the time of inclusion

    6) For Group 1, history of documented diphtheria, pertussis, or tetanus disease since participation in studies TD9707 or TD9805. For Group 2, history of documented diphtheria, pertussis, or tetanus disease in the last 10 years.

    7) For Group 1, known or suspected receipt of a diphtheria-, pertussis-, or tetanus containing vaccine since participation in study TD9707 or TD9805. For Group 2, known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine in the last 10 years.

    8) Receipt of any vaccine, other than influenza vaccine, in the 28-day period prior to V1 or scheduled to receive any vaccine, other than influenza vaccine, in the period between V1 and V2. For influenza vaccine only, defer if received in the 14 days prior to enrollment or scheduled to receive prior to V2.

    9) Receipt of blood or blood-derived products in the past 3 months

    10) Suspected or known hypersensitivity to any of the vaccine components, or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances

    11) Unable to attend the scheduled visits or to comply with the study procedures

    12) In females of childbearing potential, known pregnancy or positive serum/urine pregnancy test

    13) Breast-feeding woman

    14) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding enrollment. Planned participation in another clinical trial during the present trial period.

    15) Current alcohol or recreational drug use that may interfere with the subject'’s ability to comply with trial procedures

    16) Thrombocytopenia, bleeding disorder, anticoagulation therapy contraindicating IM vaccination

    17) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent

    Temporary Exclusion Criteria:
    Should the following conditions occur, the investigator will postpone vaccination until the condition is resolved. Enrollment may occur if the condition is resolved and enrollment is still open.

    18) Febrile illness (temperature ≥ 37.5°C [99.5°F]) at the time of inclusion. See Exclusion #5.)

    19) Short– term systemic (injected or oral) corticosteroid therapy. (See Exclusion #4.) Individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than 1 course within the last 2 weeks prior to enrollment.

    20) Receipt of vaccine, other than influenza, in the 28-day period prior to V1. Receipt of influenza vaccine in the 14-day period prior to V1. (See Exclusion #8).

    21) Other events which in the judgment of the investigator would preclude vaccination at the time of V1

    Group 3
    1) History of documented diphtheria, pertussis, or tetanus disease since participation in study TD9707 or TD9805

    2) Known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine since participation in study TD9707 or TD9805
    E.5 End points
    E.5.1Primary end point(s)
    1) Anti-diphtheria and anti-tetanus antitoxin concentrations post-vaccination (Visit 2), measured using a microneutralization assay and an enzyme-linked immunosorbent assay (ELISA), respectively, and expressed as proportions with antitoxin concentrations ≥ 0.10 IU/mL

    2) Anti-pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], fimbriae types 2 and
    3 [FIM]) antibody concentrations post-vaccination, measured using an ELISA, and expressed as geometric mean concentrations (GMCs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Post-Vaccination (Visit 2):
    Anti-diphtheria and anti-tetanus antitoxin concentrations

    Post-Vaccination:
    Anti-pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], fimbriae types 2 and 3 [FIM]) antibody concentrations
    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 No
    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 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.8.2.4Number 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
    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 years1
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 650
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 139
    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 789
    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: Canada
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