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    Summary
    EudraCT Number:2015-005627-84
    Sponsor's Protocol Code Number:Td519
    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 number2015-005627-84
    A.3Full title of the trial
    A pivotal open label, two-arm, multi-center trial to evaluate the safety and immunogenicity of a single dose of Adacel® vaccine in persons 10 to <11 years of age with the intent to extend the licensure of Adacel vaccine for use in children 10 years of age.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Adacel® Vaccine Administered to Persons 10 Years of Age.
    A.4.1Sponsor's protocol code numberTd519
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01311557
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1115-6619
    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 INC.
    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
    B.5.3.3Post codePA
    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 pertussis antibody responses induced by Adacel in persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of age.

    2) To compare the booster responses against pertussis antigens induced by Adacel in persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of age.
    E.2.2Secondary objectives of the trial
    Immunogenicity

    1) To compare seroprotection rates against tetanus and diphtheria induced by Adacel in persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of age.

    2) To compare booster responses against tetanus and diphtheria induced by Adacel in persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of age.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age is > 10 to < 12 years of age at the time of vaccination.

    2) Assent form has been signed and dated by the subject, and informed consent has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations).

    3) Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.

    4) For a female of childbearing potential, abstinence or use of an effective method of contraception from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.

    5) Documented vaccination history of receiving 5 previous doses of DTaP vaccine (consisting of 3 infant doses in the first year of life, a 4th dose in the 2nd year of life, and a 5th dose at 4 through 6 years of age).
    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, acute, or chronic disease that is unstable or that, in the opinion of the Investigator, might:
    • interfere with the ability to participate fully in the study; or
    • interfere with evaluation of the vaccine.

    3) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

    4) Prior receipt of pertussis, diphtheria, or tetanus containing vaccines within the past 5 years.

    5) A personal history of physician-diagnosed or laboratory confirmed pertussis disease within the last 2 years.

    6) A previous severe reaction to pertussis, diphtheria or tetanus vaccine including immediate anaphylaxis, encephalopathy within 7 days or seizure within 3 days of receiving the vaccine.

    7) Receipt of blood or blood-derived products in the past 3 months, which might interfere with the assessment of the immune response.

    8) Suspected or known hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.

    9) Receipt of any vaccine within 30 days of receiving study vaccine, or plans to receive another vaccine before the 2nd visit; except that influenza vaccine may have been received between 30 and 15 days (but no fewer than 15 days) before receiving study vaccine.

    10) Participation in another interventional clinical trial in the 30 days preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study (between Visit 1 and Visit 2).

    11) Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as reported by the parent/guardian.

    12) Thrombocytopenia, bleeding disorders, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination.

    13) Known pregnancy, or a positive urine or serum pregnancy test.

    14) Prior personal history of Guillain-Barré syndrome.

    15) Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.

    Temporary Contraindications:

    A prospective subject must not be included in the study until the following condition(s) and/or symptoms are resolved:
    • Febrile illness (temperature ≥100.4°F) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity
    1) Post-vaccination GMTs to PT, FHA, PRN, and FIM.

    2) Booster response rates against pertussis antigens based on anti-PT, FHA, PRN and FIM antibody titer rises between pre- and post-vaccination specimens.

    For pertussis antigens, a booster response rate is defined as a four-fold increase in pre- to postvaccination titers for subjects with pre-vaccination titers ≤ 93 EU/mL for PT, ≤ 170 EU/mL for FHA, ≤ 115 EU mL for PRN, and ≤ 285 EU/mL for FIM. If the pre-vaccination titers is >93 EU/mL for PT, >170 EU/mL for FHA, >115 EU mL for PRN, or > 285 EU/mL for FIM then a two-fold increase in the antibody titer would be defined as a booster response.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Post-vaccination
    Between Pre-to post vaccination
    E.5.2Secondary end point(s)
    1) Diphtheria and tetanus seroprotection rates based on post-vaccination antibody titers.
    2) Booster response rates against tetanus and diphtheria based on antibody titer rises between pre- and post-vaccination specimens.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Post-vaccination
    Between Pre-to post vaccination
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    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
    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 months7
    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: 1300
    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: 1300
    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
    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 1300
    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
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