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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44346   clinical trials with a EudraCT protocol, of which   7374   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2023-001084-54
    Sponsor's Protocol Code Number:DEN-306
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2025-06-13
    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 number2023-001084-54
    A.3Full title of the trial
    A Randomized, Age-Descending, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Safety and Immunogenicity of 2 Doses of a Subcutaneous Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Within the Routine Vaccination Schedule of Pediatric Participants ≥6 Months to <21 Months of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers
    A.4.1Sponsor's protocol code numberDEN-306
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/003/2024
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Vaccines, Inc.
    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 GmbH
    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.3.2Product code TAK-003
    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 INNDengue virus serotype 1 (live, attenuated)
    D.3.9.2Current sponsor codeTDV-1
    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 codeTDV-2
    D.3.9.3Other descriptive nameDengue virus, serotype 2, live, attenuated
    D.3.9.4EV Substance CodeSUB217665
    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 codeTDV-3
    D.3.9.3Other descriptive nameDengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated
    D.3.9.4EV Substance CodeSUB217717
    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 codeTDV-4
    D.3.9.3Other descriptive nameDengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated
    D.3.9.4EV Substance CodeSUB217718
    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 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
    E.1.1.1Medical condition in easily understood language
    Dengue fever is caused by infection with dengue virus, a RNA virus that occurs as 4 recognized serotypes: DENV-1, -2, -3, -4. These viruses are transmitted from human to human by mosquitoes.
    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 TDV administered as 2 doses given 3 months apart in healthy pediatric participants aged ≥6 to <21 months.
    • To assess the immunogenicity of TDV administered as 2 doses given 3 months apart in healthy pediatric participants aged ≥6 to <21 months at 1 month post second TDV dose.
    E.2.2Secondary objectives of the trial
    • To assess immunogenicity of TDV administered as 2 doses given 3 months apart in healthy pediatric participants aged ≥6 to <21 months at other specified timepoints.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participant eligibility is determined according to the following criteria:
    1. Participant is aged >=6 to <21 months at the time of entry into the trial.
    2. Participant is male or female.
    3. Participant is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and the clinical judgment of the investigator.
    4. Participant’s legally acceptable representative (LAR) has signed and dated a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedure, and after the nature of the trial has been explained according to local regulatory requirements.
    5. The participant and participant’s LAR can comply with trial procedures and can be available for the duration of follow-up, according to the LAR.
    E.4Principal exclusion criteria
    Any participant who meets any of the following criteria will not qualify for randomization:
    1. Participant has contraindication(s), warning(s) and/or precaution(s) applicable to vaccination with TDV as specified in the investigator’s brochure (IB) and/or the approved product label (as applicable) in the participating country.
    2. Participant has a known hypersensitivity or allergy to any of the investigational medicinal product (IMP) components (including excipients).
    3. Participant has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant’s ability to participate in the trial.
    4. Participant has a history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (example, Guillain-Barré syndrome).
    5. Participant has an illness, or history of any illness that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the participant due to involvement in this trial.
    6. Participant has a known or suspected impairment/alteration of immune function, including:
    a. Chronic administration of oral and/or parenteral steroids at doses considered sufficiently immunosuppressive (for example, (>=, greater than equal to) 2 mg/kg [milligrams per kilograms] body weight/day prednisone [or equivalent] for 14 consecutive days, or, >=20 milligram per day [mg/day] prednisone [or equivalent] for >=14 consecutive days) within 60 days prior to Day 1 Month 0 (M0) (note: use of corticosteroids by inhaled, intranasal, intraarticular, bursal, tendon injection, or topical routes is allowed).
    b. Receipt of blood, immunoglobulins, blood products, and/or plasma derivatives within the 3 months prior to Day 1 (M0).
    c. Receipt of immunostimulants within 60 days prior to Day 1 (M0).
    d. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (M0).
    e. HIV infection or HIV-related disease.
    f. Hepatitis B virus infection.
    g. Hepatitis C virus infection.
    h. Genetic immunodeficiency.
    7. Participant has known or suspected abnormalities of splenic or thymic function.
    8. Participant has a known bleeding diathesis, or any condition/medication that may be associated with a prolonged bleeding time.
    9. Participant has a serious chronic or progressive disease deemed to be preclusive to trial entry, that is , not medically stable according to the judgment of the investigator.
    10. Participant has previously received a vaccination against dengue virus (investigational or licensed).
    11. Participant has a clinically significant active infection (as assessed by the investigator) or body temperature greater than (>) 38.0 degrees Celsius (°C) (>100.4 degrees Fahrenheit [°F]) within 3 days of intended IMP administration on Day 1 (M0).
    12. Participant has used antipyretics and/or analgesic medications within 24 hours prior to vaccination. The reason for their use (prophylaxis vs treatment) must be documented. Trial entry must be delayed to allow for a full 24 hours to have passed since last use of antipyretics and/or analgesic medications.
    13. Participant has received any of the following:
    a. A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to IMP administration on Day 1 (M0). This includes co-administration with routine vaccines.
    b. A coronavirus vaccine within 14 days prior to IMP administration on Day 1 (M0).
    c. A vaccine authorized for emergency use within 28 days prior to IMP administration on Day 1 (M0).
    14. Participant is scheduled to receive any other vaccine within 28 days after IMP administration on Day 1 (M0).
    15. Participant is participating in any clinical trial with another investigational product 30 days prior to Day 1 (M0) or plans to participate in another clinical trial at any time during the conduct of this trial.
    16. Participant has taken part in any clinical trial of a dengue or other flavivirus (example, West Nile virus) candidate vaccine, except if it is known that the participant received placebo in the trial(s).
    17. A first degree relative is involved in the conduct of this trial.
    E.5 End points
    E.5.1Primary end point(s)
    1. Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1
    2. Number of Participants with Solicited Local (Injection Site) AEs Within 7 Days Post Vaccination at Day 90
    3. Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1
    4. Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 90
    5. Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 1
    6. Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 90
    7. Percentage of Participants With Medically-attended AE (MAAEs) from Day 1 through the end of trial (up to Day 1170)
    8. Number of Participants With Serious Adverse Events (SAEs) from Day 1 through the end of trial (up to Day 1170)
    9. Geometric Mean Titers (GMTs) of Neutralizing Antibodies by Microneutralization Test (MNT) for Each of 4 Dengue Virus Serotypes at Day 120
    E.5.1.1Timepoint(s) of evaluation of this end point
    Multiple time points occurring as stated in E.5.1
    E.5.2Secondary end point(s)
    1. GMTs of Neutralizing Antibodies by MNT for Each of the 4 Dengue Virus Serotypes at Day 1, Day 30, Day 270, Day 450, Day 810 and Day 1170
    2. Seropositivity Rates for 4 Dengue Virus Serotypes at Day 1, Day 30, Day 120, Day 270, Day 450, Day 810, and Day 1170
    3. Seropositivity Rates For Multiple (2, 3, or 4) Dengue Virus Serotypes at Day 1, Day 30, Day 120, Day 270, Day 450, Day 810, and Day 1170
    E.5.2.1Timepoint(s) of evaluation of this end point
    Multiple time points occurring as stated in Section E.5.2
    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 Yes
    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
    Colombia
    Thailand
    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 years3
    E.8.9.2In all countries concerned by the trial months3
    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: 212
    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: 212
    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 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
    Paediatric subjects aged 6 to <21 months enrolled in this study are incapable of giving consent personally and therefore content is given by parent/care giver.
    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 212
    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: Thailand
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Jun 26 12:14:48 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA