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    Summary
    EudraCT Number:2015-003941-24
    Sponsor's Protocol Code Number:Td528
    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 number2015-003941-24
    A.3Full title of the trial
    Immunogenicity and Safety of Sanofi Pasteur’s Tdap Combined Vaccine (ADACEL) as a Booster Dose, versus Local DT Vaccine in Healthy Children or versus Local Td Vaccine in Healthy Adolescents and Adults in China
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sanofi Pasteur’s Tdap Combined Vaccine as a Booster versus Local DT Vaccine in Children or versus Local Td Vaccine in Adolescents and Adults in China.​
    A.4.1Sponsor's protocol code numberTd528
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01993173
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1127-7835
    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
    B.4.2CountryChina
    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, SANOFI 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 describe diphtheria and tetanus seroprotection rates and pertussis booster response rates induced by each of the study vaccines: ADACEL vaccine (in all study age groups), local DT vaccine (in children), and local Td vaccine (in adolescents and adults)
    E.2.2Secondary objectives of the trial
    • To further describe in each group the immunogenicity of the study vaccines at baseline and 1month after the vaccination
    • To describe the safety of the study vaccines.
    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:

    1) Aged 4 through 64 years on the day of inclusion

    2) For children and adolescents (4 through 17 years): Informed consent form (ICF) signed and dated by the parent(s) or another legally acceptable representative and assent form signed and dated by the subject if aged 8 through 17 years
    For adults (18 years and over): ICF signed and dated by the subject

    3) Subject and parent / legally acceptable representative (for subjects up to 17 years) able to attend all schedule visits and to comply with all trial procedures

    4) According to China National Immunization Recommendations, written documentation of complete primary series and fourth dose of DTP vaccine for subjects aged 4 through 7 years and a written documentation or oral confirmation of complete primary series and fourth dose of DTP vaccine for subjects aged 8 through 64 years.
    E.4Principal exclusion criteria
    An individual fulfilling any of the following criteria was to be excluded from trial enrollment:

    1) Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure

    2) Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination

    3) Previous vaccination against diphtheria and tetanus disease with either the trial vaccine or another vaccine (except tetanus-prone wound management for adults) in the past 12 months

    4) Previous fifth vaccination against pertussis disease

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

    6) 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

    7) Known (laboratory-confirmed / self-reported) Human Immunodeficiency Virus (HIV) or Hepatitis C seropositivity

    8) History of diphtheria, tetanus, or pertussis infection (confirmed either clinically, serologically or microbiologically)

    9) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances

    10) Laboratory-confirmed / self-reported thrombocytopenia, contraindicating intramuscular vaccination

    11) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination

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

    13) Chronic illness that, in the opinion of the Investigator, was at a stage where it could interfere with trial conduct or completion

    14) Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 37.1°C). A prospective subject could not be included in the study until the condition had resolved or the febrile event had subsided.

    15) History of contra-indication to vaccination with pertussis containing vaccine, including:
    • Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that was not attributable to another identifiable cause
    • Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy
    • Axillary temperature >39.4°C within 48 hours not attributable to another identifiable cause
    • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours

    16) Prior personal history of Guillain-Barré syndrome

    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) Subject was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the vaccination and until at least 4 weeks after the vaccination)

    19) Current alcohol abuse or drug addiction.
    E.5 End points
    E.5.1Primary end point(s)
    Diphtheria and tetanus antibody concentrations measured by enzyme linked immunosorbent assay (ELISA) 1 month after the injection of study vaccines (at Visit 2
    [V02], i.e., V01 + 28-35 days). The following parameters were assessed:
    • Number and proportion of subjects with anti-diphtheria antibody concentrations ≥ 0.1 international unit (IU)/mL (ELISA)
    • Number and proportion of subjects with anti-tetanus antibody concentrations ≥ 0.1 IU/mL (ELISA).

    Pertussis (PT, FHA, PRN, and FIM) antibody concentrations measured by ELISA at baseline (V01) and 1 month after the injection of study vaccine (at V02, i.e., V01 + 28-35 days). The following parameters were assessed:
    • Number and proportion of subjects with a booster response for PT, FHA, PRN, and FIM:

    The criterion for demonstrating a booster response was as follows:
    • Subjects with pre-vaccination antibody concentrations less than the lower limit of quantitation (<LLOQ) demonstrated the booster response if they had postvaccinationlevels ≥ 4xLLOQ.
    • Subjects with pre-vaccination antibody concentrations ≥ LLOQ but < 4xLLOQ demonstrated the booster response if they had a 4-fold rise of their prevaccination levels (i.e., post-/pre-vaccination ≥ 4).
    • Subjects with pre-vaccination antibody concentrations ≥ 4xLLOQ demonstrated the booster response if they had a 2-fold rise of their pre-vaccination levels (i.e.,
    post-/pre-vaccination ≥ 2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Refer to Primary end point information above.
    E.5.2Secondary end point(s)
    IMMUNOGENICITY
    Diphtheria, tetanus, and pertussis (PT, FHA, PRN and FIM) antibody concentrations measured by ELISA at baseline (V01) and 1 month after the injection of study vaccines (at V02, V01 + 28-35 days). The following parameters were assessed:
    • Number and proportion of subjects with anti-diphtheria antibody concentrations ≥ 0.1 IU/mL (ELISA) at V01
    • Number and proportion of subjects with anti-tetanus antibody concentrations ≥ 0.1 IU/mL (ELISA) at V01
    • Number and proportion of subjects with anti-diphtheria antibody concentrations ≥ 1.0 IU/mL (ELISA) at V01 and V02
    • Number and proportion of subjects with anti-tetanus antibody concentrations ≥ 1.0 IU/mL (ELISA) at V01 and V02
    • Geometric mean of individual antibody concentrations (GMC) at V01 and V02 for all antibodies
    • Geometric mean of individual antibody concentrations ratio (GMCR, post / pre vaccination concentrations) (for anti-PT, anti-FHA, anti-PRN, anti-FIM, antidiphtheria and anti-tetanus antibody concentrations)

    SAFETY
    The secondary endpoints for the safety evaluation in each study group were:
    • Occurrence of any unsolicited systemic adverse events (AEs) reported within 30 minutes after the vaccination.
    • Occurrence of solicited (terms pre-listed in the electronic Case Report Form [eCRF]) injection site and systemic reactions occurring between D0 and D7 after the injection.
    • Occurrence of unsolicited AEs up to 28 days after the injection
    • Occurrence of any serious AE (SAE) occurring throughout the trial period.

    Other endpoints recorded or derived were described at the time of statistical analysis. Depending on the item, these included: nature (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), time of onset, duration, number of days of occurrence, grade of severity, relationship to vaccine, action taken, whether the AE led to early termination from the study, seriousness, or outcome.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to Secondary end point information above.
    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 Yes
    E.8.1.4Double blind No
    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? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    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
    China
    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 days35
    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: 720
    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: 720
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 720
    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
    • Informed Consent Form was signed by parent / legally acceptable representative of children and adolescents
    • Informed Consent Form was signed by subject aged 18 years and over
    • Assessment Form was signed by children aged 8 through 17 years.
    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 1200
    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: China
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