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    Summary
    EudraCT Number:2014-001694-14
    Sponsor's Protocol Code Number:CYD08
    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 number2014-001694-14
    A.3Full title of the trial
    A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines
    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 toddlers Aged 12 to 15 Months in the Philippines
    A.4.1Sponsor's protocol code numberCYD08
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01064141
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1111-5855
    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 number3304 37 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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name TRIMOVAX®
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PASTEUR
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMMR vaccine (TRIMOVAX®)
    D.3.2Product code 065
    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 INNAttenuated live measles virus, SCHWARZ strain
    D.3.9.3Other descriptive nameMEASLES VIRUS SCHWARZ STRAIN (LIVE, ATTENUATED)
    D.3.9.4EV Substance CodeSUB25680
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAttenuated live mumps virus, URABE AM 9 strain
    D.3.9.3Other descriptive nameMUMPS VIRUS URABE AM-9 STRAIN (LIVE, ATTENUATED)
    D.3.9.4EV Substance CodeSUB46921
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.7
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAttenuated live rubella virus, WISTAR RA 27/3M strain
    D.3.9.3Other descriptive nameRUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED)
    D.3.9.4EV Substance CodeSUB21610
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3
    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
    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
    Safety of CYD dengue vaccine after each injection; first injection given alone or co-administered with MMR vaccine (Trimovax).
    Dengue vaccinal viremia
    E.2.2Secondary objectives of the trial
    Immunogenicity of CYD dengue vaccine after each injection; first injection given alone or co-administered with MMR vaccine.
    Immunogenicity of MMR vaccine, given alone or co-administered with CYD dengue vaccine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Toddler in good health based on medical history and medical examination (Scr.+V_MV)
    2) Toddler aged 12 to 15 months on the day of inclusion (Scr.)
    3) Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (Scr.)
    4) Provision of informed consent form signed by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations) (Scr.)
    5) Subject and parent/delegate able to attend all scheduled visits and comply with all trial procedures (Scr.)
    6) Completion of previous vaccination program according to the national immunization schedule, except for measles (Scr.)
    E.4Principal exclusion criteria
    1) Family members from the Investigator or from the staff involved in the trial (Scr.)
    2) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion (Scr.)
    3) 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 corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) (Scr.)
    4) History of central nervous system disorder or disease, including seizures (Scr.)
    5) History of varicella, measles, mumps, rubella and hepatitis A; confirmed either clinically, serologically, or microbiologically (Scr.)
    6) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion (Scr.)
    7) Previous vaccination against MMR, hepatitis A or varicella (Scr.)
    8) Previous vaccination against FV diseases (Scr.)
    9) Known systemic hypersensitivity to any of the components of the vaccines, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances (Scr.)
    10) Planned participation in another clinical trial during the present trial period (Scr.)
    11) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination (Scr.+V_MV)
    12) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response (Scr.+V_MV)
    13) Planned receipt of any vaccine in the 4 weeks following the first trial vaccination (V_MV)
    14) Human immunodeficiency virus (HIV) seropositivity in the blood sample taken at screening visit (V_MV)
    15) Clinically significant laboratory abnormalities, as judged by the Investigator, in blood sample taken at screening visit (V_MV)
    Should one of the conditions listed below occur, the Investigator was to postpone vaccination until the condition was resolved:
    16) Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator’s judgment (Scr.+V_MV)
    17) Receipt of oral or injected antibiotic therapy within 72 hours prior to the vaccination (Scr.+V_MV)
    18) Any vaccination received in the 4 weeks preceding vaccination (Scr.+V_MV)
    E.5 End points
    E.5.1Primary end point(s)
    Safety and reactogenicity: Adverse events, serious adverse events and biological abnormalities (out-of-normal-range biological test results)
    Viremia: Dengue vaccine viruses levels in serum
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety and reactogenicity:
    - Up to day 28 (D28) after each CYD dengue vaccine injection for AEs
    - Throughout the trial for SAEs
    - At baseline (screening visit) and D8 after the first CYD dengue vaccine injection for Biological abnormalities.

    Viremia:
    - On D8 after the first CYD dengue vaccine
    E.5.2Secondary end point(s)
    Dengue Immune response (serotype specific neutralizing antibodies)
    Immune response (antibody levels) against measles, rubella, and mumps
    E.5.2.1Timepoint(s) of evaluation of this end point
    Dengue Immune response: at baseline (screening visit) and on D28 after the first, second and third CYD dengue vaccine injections .
    Immune response against measles, rubella, and mump: at baseline (screening visit) and at D28 after MMR vaccination in Groups 3 and 4.
    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) 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 (first injection) and open-label (second and third injections)
    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
    Control vaccines: varicella vaccine (OKAVAX), Hepatitis A vaccine (AVAXIM 80); Placebo (NaCl 0.9%)
    E.8.2.4Number of treatment arms in the trial4
    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
    Philippines
    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 months19
    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: 210
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 210
    F.1.1.5Children (2-11years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 210
    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: Philippines
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