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    Summary
    EudraCT Number:2023-000134-15
    Sponsor's Protocol Code Number:DEN-302
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2023-09-22
    Trial 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 number2023-000134-15
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Safety and Immunogenicity of a Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Subcutaneously to Healthy Subjects Aged 4 to 60 Years in India
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India
    A.4.1Sponsor's protocol code numberDEN-302
    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 SponsorTakeda
    B.1.3.4CountryUnited States
    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 supportTakeda
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda
    B.5.2Functional name of contact pointStudy Director
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.6E-mailmedinfoUS@takeda.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 Takeda's Dengue Tetravalent Vaccine
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDengue Tetravalent Vaccine (Live, Attenuated)
    D.3.4Pharmaceutical form 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 INNDengue virus serotype 1 (live, attenuated)
    D.3.9.2Current sponsor codeTAK-003
    D.3.9.4EV Substance CodeSUB217716
    D.3.10 Strength
    D.3.10.1Concentration unit log10 PFU/dose log10 plaque forming unit(s)/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDengue virus serotype 2 (live, attenuated)
    D.3.9.2Current sponsor codeTAK-003
    D.3.9.4EV Substance CodeSUB181519
    D.3.10 Strength
    D.3.10.1Concentration unit log10 PFU/dose log10 plaque forming unit(s)/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2.7
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDengue virus serotype 3 (live, attenuated)
    D.3.9.2Current sponsor codeTAK-003
    D.3.9.4EV Substance CodeSUB181520
    D.3.10 Strength
    D.3.10.1Concentration unit log10 PFU/dose log10 plaque forming unit(s)/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number4.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDengue virus serotype 4 (live, attenuated)
    D.3.9.2Current sponsor codeTAK-003
    D.3.9.4EV Substance CodeSUB181521
    D.3.10 Strength
    D.3.10.1Concentration unit log10 PFU/dose log10 plaque forming unit(s)/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number4.5
    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 Yes
    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 placeboInjection
    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
    E.1.1.1Medical condition in easily understood language
    Dengue
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10012310
    E.1.2Term Dengue fever
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the safety profile of Dengue Tetravalent Vaccine (TDV) administered as 2 doses given 3 months apart in healthy
    adults, adolescents, and children.
    • To evaluate the immunogenicity of TDV administered as 2 doses given 3 months apart in
    healthy adults, adolescents, and children at 1 month post second dose.
    E.2.2Secondary objectives of the trial
    • To describe immunogenicity of TDV at baseline and 6 months post second TDV dose when
    administered as 2 doses given 3 months apart.
    • To describe seropositivity (% of subjects with reciprocal neutralizing titer ≥10) at baseline,
    1 month post second TDV dose, and 6 months post second TDV dose.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants who can comply with trial procedures and are available for the duration of follow-up.
    E.4Principal exclusion criteria
    At screening and at vaccination:
    1. A body mass index (BMI) ≥35 kg/m^2.
    2. Intent to participate in another clinical trial at any time during the conduct of this trial.
    3. Plans to receive any of the following:
    a. A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to TDV or placebo administration.
    b. A coronavirus vaccine within 14 days prior to TDV or placebo administration.
    c. A vaccine authorized for emergency use within 28 days of TDV or placebo administration.
    4. Known substance or alcohol abuse within the past 2 years that may interfere with his/her ability to comply with requirements for trial participation.
    5. Receipt of previous vaccination against dengue virus.
    6. Previous participation in any clinical trial of a dengue candidate vaccine.

    At Vaccination:
    1. Participants with febrile illness or moderate or severe acute illness, or infection, at the time of random assignment.
    2. Medicated with antipyretic and/or analgesic medication(s) within 24 hours prior to TDV or placebo administration.
    E.5 End points
    E.5.1Primary end point(s)
    1. Number of Participants With Solicited Local Adverse Events (AEs) by Severity
    2. Number of Participants With Solicited Systemic AEs by Severity
    3. Percentage of Participants With Any Unsolicited AEs
    4. Percentage of Participants With an AE Leading to Participant Withdrawal
    5. Percentage of Participants With an AE Leading to TDV or Placebo Discontinuation
    6. Percentage of Participants With a Medically-attended AE (MAAE)
    7. Percentage of Participants With a Serious Adverse Event (SAE)
    8. Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Virus Serotypes
    E.5.1.1Timepoint(s) of evaluation of this end point
    Postvaccination at Day 1 and Day 90 (up to 7 days for solicited local AEs, up to 14 days for solicited systemic AEs and up to 28 days for unsolicited AEs. From vaccination through 9 months for other AEs and Day 120 for GMTs.
    E.5.2Secondary end point(s)
    1. GMTs for Each of the 4 Dengue Virus Serotypes
    2. Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes
    3. Percentage of Participants With Seroconversion for Multiple Dengue Virus Serotypes
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, Day 120 and Day 270
    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 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) 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 Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    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 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
    India
    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 months9
    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: 240
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 120
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 260
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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
    Being pediatric age group, participants were not able to give consent, thus needed parent/caregiver to sign consent.
    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 480
    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: India
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