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    Summary
    EudraCT Number:2014-001710-25
    Sponsor's Protocol Code Number:CYD23
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-05-26
    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 number2014-001710-25
    A.3Full title of the trial
    Efficacy and Safety of Dengue Vaccine in Healthy Children Aged 4 to 11 Years in Thailand
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Sanofi Pasteur's dengue vaccine in Healthy Children Aged 4 to 11 Years in Thailand to evaluate its efficacy
    A.4.1Sponsor's protocol code numberCYD23
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00842530
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1127-6970
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/113/2014
    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 SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur SA
    B.5.2Functional name of contact pointR&D, Clinical Development dpt
    B.5.3 Address:
    B.5.3.1Street Address1541 Avenue Marcel Mérieux
    B.5.3.2Town/ cityMARCY L'ETOILE
    B.5.3.3Post code69280
    B.5.3.4CountryFrance
    B.5.4Telephone number0033(0)437 65 60 60
    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.2.5The 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 nameCYD Dengue Vaccine
    D.3.2Product code 323
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive, attenuated, chimeric dengue virus serotype 1
    D.3.9.3Other descriptive nameLIVE, ATTENUATED, CHIMERIC DENGUE VIRUS
    D.3.9.4EV Substance CodeSUB165738
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4.5 to 6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive, attenuated, chimeric dengue virus serotype 2
    D.3.9.3Other descriptive nameLIVE, ATTENUATED, CHIMERIC DENGUE VIRUS
    D.3.9.4EV Substance CodeSUB165738
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4.5 to 6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive, attenuated, chimeric dengue virus serotype 3
    D.3.9.3Other descriptive nameLIVE, ATTENUATED, CHIMERIC DENGUE VIRUS
    D.3.9.4EV Substance CodeSUB165738
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4.5 to 6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive, attenuated, chimeric dengue virus serotype 4
    D.3.9.3Other descriptive nameLIVE, ATTENUATED, CHIMERIC DENGUE VIRUS
    D.3.9.4EV Substance CodeSUB165738
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4.5 to 6
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of symptomatic dengue disease
    E.1.1.1Medical condition in easily understood language
    Prevention of dengue disease with clinical symptoms
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy of dengue vaccine after three injections in preventing symptomatic virologically-confirmed dengue cases, regardless of the severity, due to any of the four serotypes
    E.2.2Secondary objectives of the trial
    Efficacy throughout the study in all subjects:
    - Symptomatic virologically-confirmed dengue cases classified as severe and due to any of the 4 serotypes > 28 days after third injection up to the end of the active phase.
    - Symptomatic virologically-confirmed dengue cases due to any of the 4 serotypes after at least two injections and after at least one injection.
    - Symptomatic virologically-confirmed dengue cases after each injection according to virus serotype.
    - Hospitalized dengue cases.
    - Duration of clinical syndrome and hospitalization for symptomatic virologically-confirmed dengue cases.

    Safety in all subjects and reactogenicity in a subset
    Dengue immune responses in a subset
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Aged 4 to 11 years on the day of inclusion.
    2) Subject in good health, based on medical history and physical examination.
    3) Provision of assent form signed by the subject (for subjects ≥ 7 years old) and informed consent form signed by the parent or another legally acceptable representative.
    4) Subject and parent/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
    5) Subject attending one of the schools involved in the trial and living in the Ratchaburi Province.
    6) For a female subject of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination.
    E.4Principal exclusion criteria
    1) Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
    2) For a female subject of child-bearing potential (girls post-menarche), known pregnancy or positive urine pregnancy test on the day of the first trial vaccination.
    3) Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
    4) Planned participation in another clinical trial during the present trial period.
    5) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or long-term systemic corticosteroids therapy.
    6) Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
    7) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
    8) Receipt of blood or blood-derived products in the past 3 months.
    9) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
    10) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
    11) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
    12) Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.
    13) Subject who planned to attend another school (outside the trial area) or move to another city in the coming 30 months.
    E.5 End points
    E.5.1Primary end point(s)
    Symptomatic virollogically confirmed dengue cases due to any of the 4 serotypes > 28 days after third injection up to the end of the active phase
    E.5.1.1Timepoint(s) of evaluation of this end point
    > 28 days after third injection up to the end of the active phase (1 year after third vaccination)
    E.5.2Secondary end point(s)
    Efficacy:
    - Symptomatic virologically-confirmed dengue cases classified as severe and due to any of the 4 serotypes > 28 days after third injection up to the end of the active phase.
    - Symptomatic virologically-confirmed dengue cases due to any of the 4 serotypes after at least two injections and after at least one injection.
    - Symptomatic virologically-confirmed dengue cases after each injection according to virus serotype.
    - Hospitalized dengue cases.
    - Duration of clinical syndrome and hospitalization for symptomatic virologically-confirmed dengue cases.

    Safety:
    Serious adverse events (SAEs) throughout the study as follows: all SAEs up to 6 months after the third injection. Related and/or fatal SAEs from 6 months after the third injection until the end of the study in all subjects.

    Reactogenicity:
    Adverse events up to D28 after each injection in the reactogenicity subset.

    Dengue immune responses:
    Dengue immune response (serotype specfic neutralizing antibodies) prior to and 28 days (D28) after each injection in an immunogenicity subset.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy:
    > 28 days after third injection up to the end of the active phase for severe cases
    After at least two injections and after at least one injection
    After each injection according to virus serotype
    Throughout the study for Hospitalized dengue cases and Duration of clinical syndrome and hospitalization for symptomatic virologically-confirmed dengue cases

    Safety:
    All SAEs up to 6 months after the third injection
    Related and/or fatal SAEs from 6 months after the third injection until the end of the study

    Reactogenicity:
    Up to D28 after each injection

    Dengue immune responses:
    Prior to and 28 days (D28) after each injection.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Observer-blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    At 0 Mo: Rabies vaccine (Cohort 1) or placebo (NaCl 0.9%); At 6 and 12 Mos: Placebo
    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
    Thailand
    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 of the Active Phase of CYD23
    Following a request from the Ethics Committee, the Passive Phase was not conducted as initially planned in CYD23 study, which was stopped after the end of the Active Phase. Hospitalized dengue cases and long-term safety follow-up up to 5 years after the third injection are being collected in a separate study (i.e., CYD57 study).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    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: 4002
    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: 4002
    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 Yes
    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 No
    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 4002
    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: Thailand
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