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    Summary
    EudraCT Number:2015-005590-20
    Sponsor's Protocol Code Number:Td518
    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 number2015-005590-20
    A.3Full title of the trial
    Safety Among Adolescents and Adults of Revaccination with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) 4 to 5 Years After a Previous Dose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL Vaccine
    A.4.1Sponsor's protocol code numberTd518
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00347958
    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
    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 LIMITED
    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 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 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
    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
    To provide safety data on revaccination with ADACEL vaccine
    E.2.2Secondary objectives of the trial
    None.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Previously received ADACEL vaccine as part of Aventis Pasteur studies Td501, Td502, or Td505.

    2) At least 15 but no greater than 69 years of age at the time of vaccination in this trial.

    3) Signed Institutional Review Board (IRB)-approved informed assent / consent form.

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

    5) For a woman, inability to become pregnant or negative serum/urine pregnancy test.
    E.4Principal exclusion criteria
    1) Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.

    2) Serious chronic disease (eg, cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) that is unstable or that might:
    • interfere with the ability to participate fully in the study; or
    • interfere with evaluation of the vaccine.

    3) Known or suspected impairment of immunologic function.

    4) Febrile illness within the last 72 hours or an oral temperature ≥100.4°F (≥38°C) at the time of inclusion.

    5) History of documented tetanus, diphtheria or pertussis disease within the preceding 5 years.

    6) Known or suspected receipt of a tetanus-, diphtheria- or pertussis-containing vaccine since participation in Study Td501, Td502, or Td505. (Receipt of Menactra vaccine at any time prior to the present study is permitted, subject to the next exclusion criterion).

    7) Received any vaccine, other than influenza vaccine, in the 28-day period prior to enrollment or scheduled to receive any vaccine, other than influenza vaccine, in the 28-day period after enrollment. For influenza vaccine only, defer if received in the 14-day period prior to enrollment or scheduled to receive in the 14-day period after enrollment.

    8) Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. 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 one course within the last two weeks prior to
    enrollment.

    9) Suspected or known hypersensitivity to any of the vaccine components or to latex.

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

    11) In females of childbearing potential, a positive or equivocal urine pregnancy test
    at enrollment.

    12) Nursing mother.

    13) Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study.

    14) Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial visits or procedures.

    15) Thrombocytopenia or bleeding disorder contraindicating IM vaccination.

    16) Subject deprived of freedom by an administrative or court order, or under the stress of an emergency setting, or hospitalized without his/her consent.
    E.5 End points
    E.5.1Primary end point(s)
    • Occurrence, time to onset, number of days of occurrence, severity, and seriousness of solicited (prelisted in the subject diary and case report form [CRF]) injection site reactions and systemic reactions occurring through 14 days after vaccination.

    • Occurrence, nature (MedDRA preferred term), time to onset, duration, severity, relationship to vaccination, and seriousness of unsolicited adverse events occurring through Visit 2.

    • Occurrence, nature (MedDRA preferred term), time to onset, duration, severity, relationship to vaccination, and seriousness of new-onset, medically-attendeda unsolicited adverse events occurring from Visit 2 through 6 months after vaccination.

    • Occurrence, nature (MedDRA preferred term), time to onset, duration, outcome, and relationship to vaccination of serious adverse events (SAEs) through 6 months after vaccination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Vaccination
    20 minutes after Adacel vaccination: monitored for immediate reactions

    Post-vaccination
    Visit 1(Day 14): record unsolicited reactions from vaccination until Day 14
    Visit 2 (28 days): record unsolicited reactions from Day 14 to to Day 28

    Safety Follow-up
    Visit 2 until 6 months: record new-onset, medically-attended unsolicited adverse events from Visit 2 through 6 months after vaccination; and record SAEs for 6 months
    E.5.2Secondary end point(s)
    None.
    E.5.2.1Timepoint(s) of evaluation of this end point
    None.
    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 No
    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 trial1
    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 months11
    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: 300
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 300
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 115
    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
    Informed consent is obtained from the subject (for subjects of legal age; for minors, subject assent and parent/guardian consent is obtained).
    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 715
    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
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