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    Summary
    EudraCT Number:2015-005628-25
    Sponsor's Protocol Code Number:Td540
    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 number2015-005628-25
    A.3Full title of the trial
    Immunogenicity and Safety of The tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (SP306) as a Booster in Japanese Adolescents
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine as a Booster in Adolescents
    A.4.1Sponsor's protocol code numberTd540
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01689324
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1124-7671
    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-Aventis K.K.
    B.1.3.4CountryJapan
    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-Aventis K.K.
    B.4.2CountryJapan
    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 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
    To assess the immunogenicity of Adacel (SP306) when administered as a single dose in Japanese adolescents.
    E.2.2Secondary objectives of the trial
    To assess the safety of Adacel (SP306) when administered as a single dose in Japanese adolescents.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 11 or 12 years and considered health on the day of inclusion

    2. Informed consent form and assent form signed and dated by the parent(s) / legal representative and the subject respectively

    3. Completed childhood vaccination against diphtheria, pertussis and tetanus (ie, received 4 doses of Japanese-produced DTaP vaccine), confirmed by checking immunization records and have not yet undergone additional DT vaccination

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

    5. For female subjects, either pre-menarchal, or post-menarchal with a negative urine pregnancy test
    E.4Principal exclusion criteria
    1. Any conditions or diseases which, in the opinion of the investigator
    - would pose a health risk to the subject
    - or might interfere with the ability to participate fully in the study
    - or might interfere with evaluation of the vaccine
    - or would otherwise make participation inappropriate according to the investigator’s clinical judgment

    2. History of diphtheria, tetanus, pertussis, confirmed either clinically, serologically, or microbiologically

    3. Known systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine

    4. Vaccination in the last 5 years against tetanus, diphtheria, and/or pertussis

    5. Known or suspected congenital immunodeficiency, or current / previous acquired immunodeficiency, or current / previous receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or current /
    previous (within the last 6 months) systemic corticosteroid therapy

    6. Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion

    7. Planned participation in another clinical trial during the present trial period

    8. Receipt of blood or blood–derived products in the past 3 months, that might interfere with assessment of the immune response

    9. Receipt of any vaccine within the 4 weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least 2 weeks before the study vaccine

    10. Planned receipt of any vaccine during the trial period

    11. Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection

    12. At high risk for diphtheria, tetanus or pertussis infection during the trial

    13. Known pregnancy, or a positive urine pregnancy test

    14. Currently breastfeeding a child

    15. Known thrombocytopenia, contraindicating IM vaccination, or a history of thrombocytopenia

    16. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination

    17. History of acute disseminated encephalomyelitis, encephalopathy, Guillain-Barré Syndrome (GBS), or autoimmune disease

    18. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

    19. Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures

    20. Identified as an employee of an Investigator, a study center, a study-affiliated vendor, or the Sponsor, with direct or indirect involvement in the proposed study or other studies under the direction of that Investigator or study center; or indentified as a spouse or child (whether natural or adopted) of such an employee

    Temporary contraindications

    A prospective subject should not be included in the study until the following conditions and/or symptoms are resolved:
    • Febrile illness (temperature ≥37.5°C)
    • Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination
    • Antipyretics/analgesics/non steroidal anti-inflammatory drugs (NSAIDs) (considered as a single category) have been administered within 4 hours prior to vaccination.
    E.5 End points
    E.5.1Primary end point(s)
    Diphtheria and tetanus
    • For diphtheria and tetanus, proportion of subjects at 28 days (window, 28-35 days) post-vaccination with antitoxin
    concentrations ≥0.1 IU/mL.

    • For diphtheria and tetanus, proportion of subjects with booster responses based on antitoxin concentration rises between pre-vaccination and 28 days (window, 28-35 days) postvaccination specimens.
    - A diphtheria booster response is defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a
    subjects with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL or a ≥ 2-fold rise in a subject with a prevaccination antitoxin concentration > 2.56 IU/mL
    - A tetanus booster response is defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.7 IU/mL

    Pertussis

    • For PT and FHA, proportion of subjects with booster responses based on antibody concentration rises between pre-vaccination and 28 days (window, 28-35 days) post-vaccination specimens.

    The criteria for demonstrating these booster responses are as follows:
    - Subjects whose pre-vaccination antibody concentrations are less than the lower limit of quantitation (LLOQ) 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 (ie, post-/prevaccination ≥ 4)
    - Subjects whose pre-vaccination antibody concentrations are ≥ 4xLLOQ will demonstrate the booster response if
    they have a 2-fold rise (ie, post-/pre-vaccination ≥ 2) (The LLOQs of the pertussis antibody assays as performed at the Sanofi Pasteur laboratory of Global Clinical Immunology in Swiftwater, Pennsylvania, USA, are 4 EU/mL for antibody to PT and 3 EU/mL for antibody to FHA.)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between Pre-Vaccination and 28 days: for pertussis, diphtheria and tetanus antibody concentration.

    Post-Vaccination at 28 days (window, 28-35 days): for diphtheria and tetanus antibody concentration.
    E.5.2Secondary end point(s)
    • Occurrence, intensity, and relationship to vaccination of any unsolicited systemic AEs reported within 30 minutes after vaccination.

    • Occurrence, time to onset, number of days of occurrence and intensity of solicited injection-site and systemic reactions (terms prelisted in the subject’s diary card and case report form [CRF]) occurring from Day 0 to Day 7 after vaccination.

    • Occurrence, nature (MedDRA preferred term), maximum intensity (for non-serious AEs only), and relationship to
    vaccination (for systemic AEs only), of unsolicited AEs up to 28 days after vaccination.

    • Occurrence, nature (MedDRA preferred term), relationship to vaccination, seriousness, and outcome of SAEs occurring for the entire duration of each subject’s involvement in the study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Vaccination:
    Day 0: 30 minutes after vaccination.

    Post-Vaccination:
    Day 0 through Day7, Day 28 and throughout the trial period.
    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) Yes
    E.7.1.1First administration to humans Yes
    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) No
    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
    Japan
    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 days61
    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: 43
    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: 43
    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
    Adolescents: Informed consent is documented by means of a
    written, signed, and dated informed consent form (ICF) by the subjects
    parent(s)/legally authorized 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 43
    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: Japan
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