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   36093   clinical trials with a EudraCT protocol, of which   5934   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:2014-001706-17
    Sponsor's Protocol Code Number:CYD06
    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 number2014-001706-17
    A.3Full title of the trial
    Safety of ChimeriVax™ Dengue Tetravalent Vaccine in Subjects Aged 2 to 45 Years in Mexico
    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 Subjects Aged 2 to 45 Years in Mexico
    A.4.1Sponsor's protocol code numberCYD06
    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 nameChimeriVax Dengue Tetravalent Vaccine
    D.3.2Product code 323
    D.3.4Pharmaceutical form 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
    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
    Safety and reactogenicity
    Viremia
    Dengue immune responses
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Aged 2 to 45 years on the day of inclusion (Scr.).
    2) Informed consent form signed by the subject, by two independent witnesses, and by the parent(s) or legal representative(s) for subjects under 18 years old (Scr.).
    3) For a woman, inability to bear a child or negative serum pregnancy test at screening (Scr.).
    4) Able to attend all scheduled visits and to comply with all trial procedures (Scr.+V01).
    5) For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least four weeks prior to the first vaccination and at least four weeks after each vaccination (Scr.+V01).
    6) For a woman, inability to bear a child or negative urine pregnancy test on the day of the first injection (V01).
    E.4Principal exclusion criteria
    1) History of thymic pathology (thymoma), thymectomy, or myasthenia (Scr.).
    2) Breast-feeding (Scr.).
    3) Systemic hypersensitivity to any of the vaccine components or history of a lifethreatening reaction to the trial vaccine or a vaccine containing the same substances (Scr.).
    4) Previous vaccination against flavivirus diseases (including Japanese encephalitis and YF) (Scr.).
    5) Current abuse of alcohol or drug addiction that might interfere with the subjects ability to comply with trial procedures (Scr.).
    6) Planned participation in another clinical trial during the present trial period (Scr.+V01).
    7) History of flavivirus infection (confirmed either clinically, serologically or microbiologically) (Scr.+V01).
    8) Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy (Scr.+V01).
    9) Chronic illness at a stage that could interfere with trial conduct or completion (Scr.+V01).
    10) Blood or blood-derived products received in the past three months (Scr.+V01).
    11) Vaccination planned in the four weeks following any trial vaccination (Scr.+V01).
    12) Flavivirus vaccination planned during the present trial period (Scr.+V01).
    13) Planned travel during the present trial period to areas with high dengue infection endemicity (Scr.+V01).
    14) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent (Scr.+V01).
    15) Participation in another clinical trial in the four weeks preceding the first trial vaccination (V01).
    16) Any vaccination in the four weeks preceding the first trial vaccination (V01).
    17) Human Immunodeficiency Virus (HIV), hepatitis B (Ag HBs) or hepatitis C (HC) seropositivity in blood sample taken at Screening (V01).
    18) Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening (V01).
    E.5 End points
    E.5.1Primary end point(s)
    Safety and reactogenicity
    Adverse events and biological abnormalities up to day 28 (D28) after each injection and serious adverse events throughout the study.

    Viremia
    Occurrence and maximum level of the four dengue serotypes in sera collected on the day of each injection, 7 and 14 days following the first and the second injections, and 7 days following the third injection in all the subjects.

    Dengue immune responses
    - Neutralizing antibody levels against each of the four parental dengue virus serotype strains of ChimeriVax™ dengue tetravalent vaccine constructs and against the Thai Mahidol four dengue virus serotype strains, were measured on sera collected in all the subjects before injection, and 28 days after the first, second, and third injections
    - Non-serotype specific Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibody levels were measured before injection and 28 days after the first, second, and third injections.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety:
    Adverse events and biological abnormalities up to day 28 (D28) after each injection and serious adverse events throughout the study.

    Viremia:
    Viremia on D0, D7 after each injection, and D14 after the first and second injections.

    Dengue immune responses:
    Immune responses (serotype specific neutralizing antibodies, and non-serotype specific immunoglobulines [IgM, IgG]) prior to first injection and on D28 after each injection.
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    First administration in pediatric population
    E.7.2Therapeutic exploratory (Phase II) No
    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 (first injection), open-label (second and third)
    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: control vaccine (yellow fever vaccine); At 3.5 and 12 Mos: tested dengue vaccine (PR1)
    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
    Mexico
    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 months14
    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: 108
    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: 72
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 36
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 18
    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 126
    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: Mexico
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA