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    Summary
    EudraCT Number:2015-005629-38
    Sponsor's Protocol Code Number:Td551
    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 number2015-005629-38
    A.3Full title of the trial
    Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents
    A.4.1Sponsor's protocol code numberTd551
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01629589
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1127-6774
    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, 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 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
    Immunogenicity
    • To describe seroprotection rates against tetanus and diphtheria in subjects randomized to receive either Adacel or Boostrix vaccine.

    • To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean antibody concentrations (GMCs) in subjects randomized to receive either Adacel or Boostrix vaccine.

    • To describe booster response rates against tetanus, diphtheria, and pertussis in subjects randomized to receive either Adacel or Boostrix vaccine.

    E.2.2Secondary objectives of the trial
    Safety
    •To describe the rates of AEs immediately post-vaccination, and the rates of unsolicited AEs and SAEs following vaccination with Adacel or Boostrix vaccine from Visit 1 through Visit 2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:

    1) Subject is 11 to < 13 years of age at the time of vaccination.

    2) Received exactly 5 doses of pertussis vaccine at < 7 years of age.

    3) Informed consent and assent forms have been signed and dated.

    4) Subject is able to attend all scheduled visits and to comply with all trial procedures.
    E.4Principal exclusion criteria
    An individual fulfilling any of the following criteria is to be excluded from trial enrollment:

    1) Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence for at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination.

    2) Any condition that, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.

    3) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.

    4) 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).

    5) Known or suspected receipt of any whole-cell pertussis-containing vaccine.

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

    7) 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.

    8) Receipt of immune globulins, blood or blood-derived products in the past 3 months.

    9) 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.

    10) Receipt of any vaccine within 30 days before 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 less than 15 days) before receiving study vaccine.

    11) Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, at the discretion of the Sponsor.

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

    13) Laboratory-confirmed thrombocytopenia, which may be a contraindication for IM vaccination, at the discretion of the Investigator.

    14) Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for IM vaccination, at the discretion of the Investigator.

    15) Personal history of Guillain-Barré syndrome.

    16) Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of vaccination. (A prospective subject should not be enrolled in the study until the condition has resolved or the febrile event has subsided.)

    17) Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

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

    19) Current alcohol or drug use that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.

    Note: Subjects enrolled into this study will not be prohibited from donating blood for non-interventional studies.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity

    Tetanus and Diphtheria:

    • Frequencies and proportions of pre- and post-vaccination tetanus and diphtheria antibody concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL among subjects in each vaccine group.

    • Pre- and post-vaccination GMCs of antibody to tetanus and diphtheria among subjects in each vaccine group.

    • Booster response rates to tetanus and diphtheria based on antibody rises pre- to post-vaccination among subjects in each vaccine group.

    • For Adacel recipients, booster response is defined as a four-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre-vaccination concentration ≤ 2.56 IU/mL for diphtheria and ≤ 2.7 IU/mL for tetanus, and defined as a two-fold increase for subjects with a pre-vaccination concentration > 2.56 IU/mL for diphtheria and > 2.7 IU/mL for tetanus.

    • For Boostrix recipients, booster response is defined as a post-vaccination titer > 4 times the lower limit of quantitation (LLOQ) for subjects with a pre-vaccination titer < LLOQ, a post-vaccination titer > 4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4xLLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer > 4xLLOQ.

    • Reverse cumulative distribution curves (RCDCs) for each vaccine group.

    Pertussis:

    • Pre- and post-vaccination GMCs of antibody to PT, FHA, PRN, and FIM among subjects in each vaccine group.

    • Booster response rates to PT, FHA, PRN, and FIM pre- to post-vaccination among subjects in each vaccine group.

    • For Adacel recipients, booster response is defined as a four-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre-vaccination concentration ≤ 93 EU/mL for PT, ≤ 170 EU/mL for FHA, ≤ 115 EU mL for PRN, or ≤ 285 EU/mL for FIM, and defined as a two-fold increase for subjects with a pre-vaccination concentration > 93 EU/mL for PT, >170 EU/mL for FHA, >115 EU/mL for PRN, or > 285 EU/mL for FIM.

    • For Boostrix recipients, booster response is defined as a post-vaccination titer > 4 times the LLOQ for subjects with a pre-vaccination titer < LLOQ, a post-vaccination titer > 4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4xLLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer > 4xLLOQ.

    • RCDCs for each vaccine group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pre-and Post-Vaccination: for pertussis, diphtheria and tetanus antibody concentrations, GMCs of antibodies and booster response rates.

    E.5.2Secondary end point(s)
    1) Occurrence, nature (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), duration, intensity, and relationship to vaccination of adverse events (AEs) reported in the 15 minutes after vaccination.

    2) Occurrence, nature (MedDRA preferred term), time to onset, duration, intensity, action taken, relationship to vaccination (for systemic AEs only), and whether the event led to early termination from the study, of unsolicited AEs from Visit 1 to Visit 2.

    3) Occurrence, nature (MedDRA preferred term), time to onset, duration, seriousness criteria, relationship to vaccination, outcome, and whether the SAE led to early termination from the study, of serious adverse events from Visit 1 to Visit 2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Vaccination:
    Visit 1(Day 0): 15 minutes after vaccination.

    Post-Vaccination:
    Visit 1 to Visit 2 (approximately 28 days after 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 Yes
    E.6.13.1Other scope of the trial description
    Observational study
    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 Yes
    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) 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
    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 months4
    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: 420
    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: 410
    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 420
    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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