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    Summary
    EudraCT Number:2020-002854-25
    Sponsor's Protocol Code Number:CYD65
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-09-13
    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 number2020-002854-25
    A.3Full title of the trial
    Immunogenicity and Safety of Tetravalent Dengue Vaccine Given in 1-, 2-, or 3-Dose Schedules (STAGE I) Followed by a Single Booster Injection of the Same Vaccine (STAGE II) 1 or 2 Years after the Last Primary Dose in Healthy Subjects 9 to 50 Years of Age in Colombia and the Philippines
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Two-stage, observer-blind, randomized, Phase II immunogenicity and safety study of tetravalent CYD dengue vaccine administered as a 1-, 2-, or 3-dose regimen (STAGE I) followed 1 or 2 years after the last primary dose by a single booster dose of CYD dengue vaccine (STAGE II).
    A.4.1Sponsor's protocol code numberCYD65
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02628444
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1161-3242
    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.4.2CountryFrance
    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 pointTrial Transparency Team
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ city-
    B.5.3.3Post code-
    B.5.3.4CountryFrance
    B.5.6E-mailContact-US@sanofi.com
    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 Yes
    D.2.1.1.1Trade name Dengvaxia
    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 nameLive, attenuated, tetravalent dengue virus vaccine
    D.3.4Pharmaceutical form Powder and solvent for solution 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, tetravalent dengue virus vaccine
    D.3.9.3Other descriptive nameDENGUE TETRAVALENT VACCINE (LIVE, ATTENUATED)
    D.3.9.4EV Substance CodeSUB181517
    D.3.10 Strength
    D.3.10.1Concentration unit CCID50/dose cell culture infective dose 50/dose
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4.5 to 6.0
    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
    Dengue Fever
    Dengue Hemorrhagic Fever
    E.1.1.1Medical condition in easily understood language
    Dengue Fever
    Dengue Hemorrhagic Fever
    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
    Immunogenicity:
    STAGE1:
    •To demonstrate the non-inferiority (NI) of the immune response elicited against each dengue serotype by the CYD dengue vaccine given as a 2-dose schedule (Group2) compared to the immune response elicited by CYD dengue vaccine given as a 3-dose schedule (Group1), in subjects seropositive at baseline, 28 days post-final injection and 1 year after last injection, both in terms of Geometric Mean Ratio (GMR).
    STAGE2:
    •To demonstrate the NI of the immune response elicited against each dengue serotype, in subjects seropositive at baseline, 28 days after administration of a booster dose of CYD dengue vaccine, in terms of geometric mean of titer ratio(GMTR, within a group) or GMR(between groups):
    Booster Dose at 1Year
    •Post-Year 1 booster Group 1/post-Dose-3 Group 1 (GMTR)
    •Post-Year 1 booster Group 2/post-Dose 3 Group 1 (GMR)
    Booster Dose at 2Years
    •Post-Year 2 booster Group 1/post-Dose 3 Group 1 (GMTR)
    •Post-Year 2 booster Group 2/post-Dose 3 Group 1 (GMR)
    E.2.2Secondary objectives of the trial
    Immunogenicity:
    To describe the neutralizing Ab levels of each dengue serotype at 28D (STAGE1):
    -post-Inj 3 to the Ab levels immediately before receiving booster injection, by baseline serostatus in all 3grps
    -post-Inj 2 and 28D post-Inj3 from Grp1 in a primary series schedule by baseline serostatus
    To demonstrate the superiority of the immune response elicited:
    -by the dengue vaccine given as a 2dose schedule (Grp2) compared to that given as a 3dose schedule (Grp1) in subjects seropositive at baseline 28D post-final inj and 1Y post-final inj, both in terms of GMR (STAGE1)
    -against each dengue serotype in subjects seropositive at baseline 28D after administration of a booster dose of dengue vaccine in terms of GMTR or GMR(STAGE2)
    To describe the seroconversion rate 28D after booster injection in all 3groups
    Safety:
    To describe all hospitalized VCD cases that have occurred at any time during the trial
    To evaluate the safety profile of dengue vaccine after any injection
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A potential subject had to meet all of the following criteria to be considered for study
    enrollment:
    1 - Aged 9 to 50 years on the day of enrollment*
    2 - Subject in good health, based on medical history and physical examination
    3 - Assent form (AF) or informed consent form (ICF) has been signed and dated by the subject (based on local regulations), and ICF 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 and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures

    * “9 to 50 years” means from the day of the 9th birthday to the day before the 51st birthday
    E.4Principal exclusion criteria
    A potential subject meeting any of the following criteria was ineligible for study enrollment:
    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 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
    3 - 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 corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the
    past 3 months)
    4 - 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**
    5 - Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion***
    6 - Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
    7 - Planned receipt of any vaccine in the 4 weeks following any trial vaccination
    8 - Previous vaccination against dengue disease with either the trial vaccine or another vaccine
    9 - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
    10 - Current alcohol abuse or drug addiction that, based on Investigator’s judgment, may interfere with the subject´s ability to comply with trial procedures.
    11 - Identified as a site employee of the Investigator, with direct involvement in the proposed study or other studies under the direction of that Investigator or study
    center, as well as family members (ie, immediate, husband, wife, and their children, adopted or natural) of the employees or the Investigator
    12 - A prospective subject must not be included in the study until the following conditions and/or symptoms are resolved:
    • Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to Investigator’s judgment) on the day of vaccination
    • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
    * For pre-menarche females, young female subjects will declare if they have not yet started menstruation; if a young female subject reaches menarche during the study, she is to be considered as a woman of childbearing potential from that time forward.
    ** The components of CYD dengue vaccine and placebo are listed in this synopsis and in the Investigator’s Brochure.
    *** Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, autoimmune disorders, diabetes, psychiatric disorders, or chronic infection.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint(s) for the evaluation of immunogenicity are:
    STAGE I:
    1- Neutralizing Ab titers against each dengue virus serotype in the Group 1 and Group 2 primary series schedules
    2- Neutralizing Ab titers against each dengue virus serotype in the Group 1 and Group 2primary series schedules
    STAGE II:
    3- Neutralizing Ab titers against each dengue virus serotype
    E.5.1.1Timepoint(s) of evaluation of this end point
    [1]: 28 days after the last CYD dengue vaccine injection
    [2]: 1 year after the last CYD dengue vaccine injection
    [3]: 28 days post-booster dose (Year 1 and Year 2, respectively, for each group that will be tested for NI in STAGE II)
    E.5.2Secondary end point(s)
    Immunogenicity endpoints are:
    STAGE I:
    1- Neutralizing Ab titers against each dengue virus serotype in all 3 groups
    STAGE II:
    2- Neutralizing Ab titers against each dengue virus serotype in all 3 groups
    3- Seroconversion rates percentages of subjects with either a pre-booster titer < 10 (1/dil) and a post-booster titer ≥ 40 (1/dil), or a pre-booster titer ≥ 10 (1/dil) and a ≥ 4-fold increase in postbooster titer as determined immediately prior to and 28 days post-booster in all 3 groups.
    Safety Endpoints are:
    STAGE I and STAGE II
    4- Occurrence, nature (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), duration, intensity, action taken, whether it leads to discontinuation or not, and relationship to vaccination of any AEs reported.
    5- Occurrence, time to onset, number of days of occurrence, intensity, whether it leads to discontinuation or not, and action taken of solicited (prelisted in the subject’s diary card and electronic case report form [eCRF]) injection site reactions (pain, erythema, and swelling) occurring.
    6- Occurrence, time to onset, number of days of occurrence, intensity, whether it leads to discontinuation or not, and action taken of solicited systemic reactions (fever, headache, malaise, myalgia, and asthenia) occurring.
    7- Occurrence, nature (MedDRA preferred term), time to onset, duration, intensity, whether it leads to discontinuation or not, action taken and relationship to vaccination (for systemic AEs only).
    8- Occurrence, nature (MedDRA preferred term), time to onset, duration, intensity, action taken, and relationship to vaccination of non-serious AESIs occurring up to 7 days after injection.
    9- Occurrence of SAEs, including serious AESIs (with specific time windows according to the nature of the event).
    10- Occurrence of hospitalized VCD cases (ie, from D0 through end of study).
    E.5.2.1Timepoint(s) of evaluation of this end point
    [1] : 28 days post-Injection 2 in Group 1, 28 days post-Injection 3, and 1 year post-injection 3
    [2] : 28 days post-Injection 3 in Group 1, immediately prior to booster injection and 28 days post-booster injection
    [3] : 28 days after injection for each of the 4 parental dengue virus strains of CYD dengue vaccine:
    [4] : in the 30 minutes after injection
    [5], [8] : up to 7 days after injection
    [6] : up to 14 days after vaccination
    [7] : up to 28 days after injection
    [9], [10] : throughout the trial
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    Colombia
    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
    Last telephone contact
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years4
    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: 326
    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: 158
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 168
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 667
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children and adolescents
    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 1050
    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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