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    Summary
    EudraCT Number:2014-001716-19
    Sponsor's Protocol Code Number:CYD15
    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 number2014-001716-19
    A.3Full title of the trial
    Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America
    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 and Adolescents Aged 9 to 16 Years in Latin America to evaluate its efficacy
    A.4.1Sponsor's protocol code numberCYD15
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01374516
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1116-4986
    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 CYD dengue vaccine after 3 vaccinations at 0, 6 and 12 months 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 of CYD dengue vaccine in preventing:
    - Symptomatic virologically-confirmed dengue cases 28 days (D28) after the third injection up to the end of the active phase due to at least 3 serotypes and due to each of the 4 serotypes.
    - Symptomatic virologically-confirmed dengue cases after at least 1 dose due to any of the 4 serotypes, due to at least 3 serotypes, and due to each of the 4 serotypes.
    - Symptomatic virologically-confirmed dengue cases after 2 doses due to any of the 4 serotypes, due to at least 3 serotypes, and due to each of the 4 serotypes.

    Safety in all subjects and reactogenicity in a subset

    Dengue immune response in a subset
    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 enrolment:
    1) Aged 9 to 16 years on the day of inclusion and resident of the site zone
    2) Subject in good health, based on medical history and physical examination
    3) Assent form or informed consent form has been signed and dated by the subject (based on local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations)
    4) Subject 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 enrolment:
    1) Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination)
    2) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
    3) Planned participation in another clinical trial during the present trial period
    4) Self-reported 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 corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
    5) Self-reported seropositivity for Human Immunodeficiency Virus (HIV) infection
    6) Self-reported systemic 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
    7) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
    8) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
    9) Planned receipt of any vaccine in the 4 weeks following any trial vaccination
    10) Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily
    11) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
    12) Identified as a site employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member (i.e., immediate, husband, wife and their children, adopted or natural) of the site employees or the Investigator

    Temporary Contraindications
    A prospective subject should not be included in the study until the following condition and/or symptoms are resolved:
    13) Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination
    14) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
    E.5 End points
    E.5.1Primary end point(s)
    Symptomatic virologically-confirmed dengue cases due to any of the 4 serotypes > 28 days after the third injection up to the end of the active phase
    E.5.1.1Timepoint(s) of evaluation of this end point
    > 28 days after the third injection up to the end of the active phase (1 year after the third vaccination)
    E.5.2Secondary end point(s)
    Efficacy:
    - Symptomatic virologically-confirmed dengue cases 28 days (D28) after the third injection up to the end of the active phase due to at least 3 serotypes and due to each of the 4 serotypes.
    - Symptomatic virologically-confirmed dengue cases after at least 1 dose due to any of the 4 serotypes, due to at least 3 serotypes, and due to each of the 4 serotypes.
    - Symptomatic virologically-confirmed dengue cases after 2 doses due to any of the 4 serotypes, due to at least 3 serotypes, and due to each of the 4 serotypes.

    Safety: Serious adverse events and adverse events of special interest (AESIs)
    Reactogenicity: Non-serious AESIs and adverse events

    Dengue immune response: serotype specific neutralizing antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: See endpoint

    Safety throughout the study.
    Reactogenicity: Non-serious AESIs up to 7 days after each injection and adverse events up to D28 after each injection

    Dengue immune response prior to first injection, after the second and third injections, and each year during 5 years after the third 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) 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 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 Yes
    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
    Brazil
    Colombia
    Honduras
    Mexico
    Puerto Rico
    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 years6
    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: 20875
    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: 9461
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 11414
    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 20875
    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
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