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    Summary
    EudraCT Number:2015-005589-43
    Sponsor's Protocol Code Number:Td508
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-01-12
    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 number2015-005589-43
    A.3Full title of the trial
    Safety and immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (ADACEL™) Vaccine compared to Component Pertussis Vaccine and Diphtheria and Tetanus Toxoids Adsorbed Combined with Inactivated Poliomyelitis Vaccine (QUADRACEL™) as fifth dose in children 4-6 years of age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Immunogenicity of ADACEL™ (TdcP Vaccine) Compared with QUADRACEL™ (HCPDT-mIPV Vaccine) as Fifth Dose in Children 4-6 Years of Age
    A.4.1Sponsor's protocol code numberTd508
    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 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 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 immunogenicity of the tetanus and lower dose diphtheria toxoids of ADACEL™ with QUADRACEL™ when given as a fifth dose.

    2. To compare the redness, swelling, pain, and fever rates after the ADACEL™ dose with the rates of these adverse events observed after the QUADRACEL™ dose when given as a fifth dose.
    E.2.2Secondary objectives of the trial
    1. To assess the immunogenicity of diphtheria and tetanus toxoids in terms of GMTs and four-fold rises in both treatment groups.

    2. To assess the immunogenicity of all pertussis antigens in terms of GMTs and four-fold rises in both treatment groups.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject must meet all the following criteria in order to be included in the study:

    1. Age > 4 years and < 7 years.

    2. Signed and dated IRB approved informed consent form obtained prior to the first study intervention.

    3. Judged to be in good health on the basis of reported medical history and examination.

    4. Plans to remain in the study area for the length of the trial.

    5. Parent or legal guardian can read and write English/French and can understand the informed consent documents and the study instructions and is mentally competent to give consent.

    6. Parent or legal guardian has access to a telephone.

    7. Has documentation of complete primary series and fourth dose, consisting of exactly four previous administrations of the pentavalent HCPDT-mIPV/PRP-T vaccine (PENTACEL™).
    E.4Principal exclusion criteria
    A subject who meets any of the following criteria will not be eligible for inclusion in the study:

    1. Known or suspected primary or acquired disease of the immune system, including autoimmune diseases such as rheumatoid arthritis or inflammatory bowel disease.

    2. Any unstable, significant underlying chronic disease, including, but not limited to, malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder.

    3. Receipt of immunosuppressive therapy for chronic immune disorders or malignancy.

    4. Daily use of oral or inhaled corticosteroids for any medical conditions: e.g. daily systemic prednisone > 1 mg/kg (However, topical corticosteroids or inhaled corticosteroids that are taken on an occasional basis, or for < 7 days, as long as there are not two courses within the previous two weeks prior to vaccination, are not an exclusion criterion.).

    5. Daily use of non-steroidal anti-inflammatory drugs (NSAIDS).

    6. Seizures disorder due to epilepsy or any other known neurologic impairment, whether active or medically controlled.

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

    8. Receipt of any other vaccine or of allergy shots within the past 30 days, or planning to receive another vaccine or allergy shots before completion of the study.

    9. Receipt of an investigational product as part of another clinical trial within the past 30 days, or planning to receive another investigational product before completion of the study.

    10. Receipt of blood products or immunoglobulin within the past 3 months.

    11. Personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the past 30 months.

    12. Known or suspected allergy to any of the vaccines or vaccine components intended for use in the study.

    13. Previous severe reactions to any of the vaccines used in this study, including anaphylaxis immediately following the vaccine, seizure within 3 days of receiving the vaccine, or encephalopathy within 7 days of receiving the vaccine.

    Temporary Contraindications for All Immunizations (the dose will be deferred)

    A subject who meets either of the following criteria at the time of planned vaccination will have enrollment deferred until complete resolution of symptoms:

    1. Oral temperature > 38.0 degrees C

    2. Known or suspected acute infectious respiratory illness, with one or more of the following active symptoms and signs: rhinorrhea, new cough, pharyngitis, and respiratory problems (e.g., wheezing, shortness of breath).
    E.5 End points
    E.5.1Primary end point(s)
    Expected Response Levels for Diphtheria and Tetanus clinical endpoints:

    Antigen Primary Clinical Endpoints Expected Response Levels Power
    (95% CI with N=600)
    Diphtheria IU/mL % > = 0.1 98% 98%
    Tetanus IU/mL % > = 0.1 99% 98%

    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety
    Post-Vaccination: Day 0 to day 14 post-vaccination or until resolution and until study completion (4–6 weeks after vaccination).

    Immunogenicity
    Pre-Vaccination and Post-Vaccination 4 to 6 weeks:
    Antibody levels for diphtheria, tetanus, and pertussis
    E.5.2Secondary end point(s)
    Safety:
    The occurrence, intensity and relationship to vaccination of adverse events (AEs) reported within the first 24 hours and 72 hours.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Severe Redness (>= 3.5 cm) - Within first 24 hours

    Any Redness - Within first 72 hours

    Severe Swelling (>= 3.5 cm) - Within first 24 hours

    Any Swelling - Within first 72 hours

    Pain - Within first 72 hours

    Fever (>= 38 degrees C) - Within first 24 hours

    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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
    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 months5
    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: 600
    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: 600
    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
    Written informed consent obtained from the study participant’s parent or legal guardian prior to enrolling the participant in the study. The consent form will be signed and dated prior to the first study intervention.
    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 600
    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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