Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   37749   clinical trials with a EudraCT protocol, of which   6186   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-003950-41
    Sponsor's Protocol Code Number:Td536
    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 number2015-003950-41
    A.3Full title of the trial
    Immunogenicity and safety of the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (SP306) given intramuscularly compared to Diphtheria and Tetanus toxoids adsorbed (DT) given subcutaneously in Japanese adolescents 11 – 12 years of age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of SP306 given intramuscularly compared to DT BIK® given subcutaneously in Japanese adolescents 11 to 12 years old​
    A.4.1Sponsor's protocol code numberTd536
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02089347
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1124-7550
    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 SA
    B.1.3.4CountryFrance
    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 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 RoleComparator
    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] - Immune System Diseases [C20]
    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 demonstrate the non-inferiority of SP306 versus DT (DT Biken 0.1 mL) vaccine in terms of diphtheria and tetanus booster response rate (proportion of subjects with booster responses) and seroprotection rate (percentage of subjects with antitoxin concentrations ≥0.1 IU/mL) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age.

    To evaluate the immune response of SP306 against the pertussis antigens PT and FHA in terms of booster response rate (proportion of subjects with booster responses) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age.
    E.2.2Secondary objectives of the trial
    IMMUNOGENICITY
    To further evaluate the immune response of the study vaccines against diphtheria, tetanus and pertussis antigens.

    SAFETY
    To assess the safety of the study vaccines after one injection in Japanese adolescents 11-12 years of age.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    An individual had to fulfill all of the following criteria in order to be eligible for trial
    enrollment:

    I 01. Aged 11 or 12 years and considered health on the day of inclusion

    I 02. Informed consent form and assent form signed and dated by the parent(s) / legal representative(s) and the subject respectively

    I 03. Completed childhood vaccination against diphtheria, pertussis and tetanus (i.e., received 4 doses of Japanese produced DTaP vaccine), confirmed by checking immunization records and have not yet undergone additional DT vaccination

    I 04. Able to attend all scheduled visits and to comply with all trial procedures

    I 05. For female subjects, either pre-menarchal or post-menarchal, with a negative urine pregnancy test
    E.4Principal exclusion criteria
    An individual fulfilling any of the following criteria was excluded from trial enrollment:

    E01. 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

    E02. History of diphtheria, tetanus, pertussis, confirmed either clinically, serologically, or microbiologically

    E03. Suspected or known 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

    E04. Vaccination in the last 5 years against tetanus, diphtheria, and/or pertussis

    E05. 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

    E06. Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion

    E07. Planned participation in another clinical trial during the present trial period

    E08. Receipt of blood or blood–derived products in the past 3 months, that might interfere with assessment of the immune response

    E09. 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

    E10. Planned receipt of any vaccine during the trial period

    E11. Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection

    E12. At high risk for diphtheria, tetanus or pertussis infection during the trial

    E13. Known pregnancy, or a positive urine pregnancy test

    E14. Currently breastfeeding a child

    E15. Known thrombocytopenia or history of thrombocytopenia

    E16. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding

    E17. History of acute disseminated encephalomyelitis, encephalopathy, Guillain-Barré Syndrome (GBS), or autoimmune disease

    E18. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

    E19. Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures

    E20. 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 identified as a spouse or child (whether natural or adopted) of such an employee
    E.5 End points
    E.5.1Primary end point(s)
    Diphtheria and tetanus
    Proportion of subjects with booster responses based on diphtheria and tetanus antitoxin concentration rises between pre-vaccination and 28 days (window, 28-35 days) post-vaccination specimens.
    - A diphtheria booster response was defined as a ≥4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤2.56 IU/mL or a ≥2-fold rise in a subject with a pre-vaccination antitoxin concentration >2.56 IU/mL
    - A tetanus booster response was 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

    Proportion of subjects at 28 days (window, 28-35 days) post-vaccination with diphtheria and tetanus antitoxin concentrations ≥0.1 IU/mL (seroprotective
    level)

    Pertussis
    Proportion of subjects with booster responses against pertussis antigens (PT and FHA) based on antibody concentration rises between pre-vaccination and 28 days (window, 28-35 days) post-vaccination specimens.
    - For subjects whose pre-vaccination antibody concentrations were less than the lower limit of quantitation (LLOQ) , a booster response was demonstrated if they had post-vaccination levels ≥4xLLOQ
    - For subjects whose pre-vaccination antibody concentrations were ≥LLOQ but <4xLLOQ, a booster response was demonstrated if they had a 4-fold rise (i.e., post-/pre-vaccination ≥4)
    - For subjects whose pre-vaccination antibody concentrations were ≥4xLLOQ, a booster response was demonstrated if they had a 2-fold rise (i.e., post-/pre-vaccination ≥2) (The LLOQs of the pertussis antibody assays as performed at GCI were 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
    Refer to primary end point information above for timepoints of evaluation.
    E.5.2Secondary end point(s)
    Immunogenicity

    Diphtheria and tetanus
    • Proportion of subjects with pre-vaccination diphtheria and tetanus antitoxin concentrations ≥0.1 IU/mL

    • Proportion of subjects with pre-vaccination and 28 days (window, 28-35 days) post-vaccination diphtheria and tetanus antitoxin concentrations ≥0.01, and ≥1.0 IU/mL

    • Diphtheria and tetanus antitoxin geometric mean concentrations (GMC) at pre-vaccination and 28 days (window, 28-35 days) post-vaccination
    • Diphtheria and tetanus antitoxin geometric mean fold rises (GMFR) between pre- and post-vaccination blood samples

    Pertussis
    Proportion of subjects with booster responses against pertussis antigens (PRN and FIM) based on antibody concentration rise between pre-vaccination and
    28 days (window, 28-35 days) post-vaccination specimens.
    - For subjects whose pre-vaccination antibody concentrations were less than LLOQ, a booster response was demonstrated if they had post-vaccination levels ≥4xLLOQ
    - For subjects whose pre-vaccination antibody concentrations were ≥LLOQ but <4xLLOQ, a booster response was demonstrated if they had a 4-fold rise (i.e., post-/pre-vaccination ≥4)
    - For subjects whose pre-vaccination antibody concentrations were ≥4xLLOQ, a booster response was demonstrated if they had a 2-fold rise (i.e., post-/pre-vaccination ≥2) (The LLOQs of the pertussis antibody assays as performed at GCI were 4 EU/mL for antibody to both PRN and FIM.)

    • Pertussis antibody (PT, FHA, PRN and FIM) GMC pre-vaccination and 28 days (window, 28-35 days) post-vaccination

    • Pertussis antibody (PT, FHA, PRN and FIM) GMFR between pre- and post-vaccination blood samples

    • Pertussis antibody (PT and FHA) measured by ELISA kit manufactured by DENKA SEIKEN Co., Ltd. in Japan:
    - Proportion of sero-positive – defined as antibody concentration ≥10 EU/mL – at pre-vaccination and 28 days (window, 28-35 days) post-vaccination
    - GMC at pre-vaccination and 28 days (window, 28-35 days) post-vaccination
    - GMFR between pre- and post-vaccination blood samples
    - Safety

    • Occurrence, intensity, and relationship to vaccination of any unsolicited systemic AEs reported within the 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 electronic case report form [eCRF]) 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
    Refer to secondary end point information above for timepoints of evaluation.
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 No
    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 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
    E.8.9.2In all countries concerned by the trial days5
    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: 534
    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: 534
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Prior to the subject's participation in the trial, 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 534
    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
    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA