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    Summary
    EudraCT Number:2022-003456-13
    Sponsor's Protocol Code Number:DEN-313
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2022-12-21
    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 number2022-003456-13
    A.3Full title of the trial
    An Open Label, Phase 2 Study to Investigate Cell-mediated Immunity and Safety of a Tetravalent Dengue Vaccine Candidate (TDV) Administered Subcutaneously in Healthy Children Aged 4 to 16 Years
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
    A.4.1Sponsor's protocol code numberDEN-313
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02948829
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1184-1893
    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 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 Vaccines, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Vaccines, Inc.
    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-mailTrialDisclosures@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 Qdenga®
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma 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 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 codeTDV-2
    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.3.10 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.3.10 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
    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, or -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 LLT
    E.1.2Classification code 10012312
    E.1.2Term Dengue fever virus infection
    E.1.2System Organ Class 100000004862
    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 cellular immune responses to 2 doses of TDV in healthy participants aged 4 to 16 years at 1 month post second vaccination.
    E.2.2Secondary objectives of the trial
    1. To assess cellular immune responses to 2 doses of TDV in healthy participants aged 4 to 16 years up to 3 years post second vaccination.
    2. To assess cellular immune responses to 2 doses of TDV in healthy participants aged 4 to 16 years by region and dengue Baseline seropositivity status.
    3. To characterize phenotype of cellular immune responses to TDV by cytokine staining (ICS) in a subset of study participants.
    4. To assess the post-vaccination neutralizing antibody response against each dengue serotype.
    5. To assess the post-vaccination neutralizing antibody response against multiple dengue serotypes.
    6. To describe the safety of 2 doses of TDV in healthy participants aged 4 to 16 years.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Is aged 4 to 16 years, inclusive (Latin America) or 4 to 8 years, inclusive (Asia).
    2. Are in good health at the time of entry into the study as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator.
    E.4Principal exclusion criteria
    1. Febrile illness (body temperature ≥38°C) or moderate or severe acute illness or infection at the time of enrolment.
    2. History or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose an additional risk to the participant due to participation in the study.
    3. Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccines within 28 days after Day 1 (Month 0).
    4. Previous participation in any clinical study of a dengue candidate vaccine, or previous receipt of any dengue vaccines (investigational or licensed).
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of Participants With Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month post second vaccination (Day 120)
    E.5.2Secondary end point(s)
    1. Magnitude of Cellular Immune Response Assessed by Number of Spot Forming Cells (SFC)/Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by IFN-γ ELISPOT at 1 Month Post Second Vaccination (Day 120)
    2. Percentage of Participants With Cellular Immune Response to TDV at 1 Month Post First Vaccination (Day 30), Pre-second Vaccination, 6 Months Post Second Vaccination (Day 270)
    3. Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First Vaccination (Day 30), Pre-second Vaccination, 6 Months Post Second Vaccination (Day 270)
    4. Percentage of Participants With Cellular Immune Responses to TDV at 1 Month Post First Vaccination (Day 30), Pre-second Vaccination, 1 and 6 Months Post Second Vaccination Post Second Vaccination (Days 120 and Days 270) Assessed by Country
    5. Percentage of Participants With Cellular Immune Responses to TDV:1 Month Post First Vaccination (Day 30), Pre-second Vaccination, 1 and 6 Months Post Second Vaccination Post Second Vaccination (Days 120 and Days 270), by Dengue Baseline Seropositivity Status
    6. Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First (Day 30), Pre- Second Vaccination, 1 and 6 Months Post Second Vaccination (Days 120 and Days 270), by Country
    7. Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT 1 Month Post First (Day 30); Pre-second Vaccination; 1 and 6 Months Post Second Vaccination (Days 120 and Days 270), by Dengue Baseline Seropositivity Status
    8. Percentage of Participants With Cellular Immune Response to TDV in Participants >10 Years of Age at Day 14
    9. Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT in Participants >10 Years of Age at Day 14
    10. Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response to DENV-2 NS Proteins at 1 Month Post First (Day 30), Pre-second Vaccination, 1 and 6 Months Post Second Vaccination (Days 120 and Days 270)
    11. Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response DENV-2 NS Proteins,1 Month Post First (Day 30), Pre Second Vaccination;1 and 6 Months Post Second Vaccination (Days 120 and Days 270), by Country
    12. Phenotype Characterization of Cellular Immune Response by Percentage of Total T Cells DENV-2 NS Proteins at 1 Month Post First (Day 30), Pre Second Vaccination,1 and 6 Months Post Second Vaccination (Days 120 and Days 270), by Dengue Baseline Seropositivity Status
    13. Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination (Day 30), Pre Second Vaccination (Day 90), and 1, 6 Months Post Second Vaccination (Days 120 and Days 270) and Then Annually Up to 3 Years (Years 1, 2 and 3)
    14. Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination (Day 30), Pre-second Vaccination (Day 90), and 1, 6 Months Post Second Vaccination (Days 120 and Days 270) and Then Annually up to 3 Years (Years 1, 2 and 3)
    15. Percentage of Participants Seropositive for Multiple Dengue Serotypes at 1 Month Post First Vaccination (Day 30), Pre Second Vaccination (Day 90), 1, 6 Months Post Second Vaccination (Days 120 and Days 270) and Annually up to 3 Years (Years 1, 2 and 3)
    16. Percentage of Participants Experiencing Non-Serious Unsolicited Adverse Events (AEs) During the 28-Day Period (Day of Vaccination + 27 Subsequent Days) After Administration of Each Vaccine Dose on Day 1 [Month 0] and Day 90 [Month 3]
    17. Percentage of Participants With Medically Attended AEs (MAAEs) From First Vaccination (Day 1) Up To 6 Months Post Second Vaccination (Day 270)
    18. Percentage of Participants With Serious Adverse Events (SAEs) From First Vaccination (Day 1) Up To End Of Study (Approximately 3 Years)
    19. Percentage of Participants With Virologically Confirmed Dengue From First Vaccination (Day 1) up to 6 Months Post Second Vaccination (Day 270)
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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
    Panama
    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 years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    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: 200
    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: 190
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    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 200
    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: Panama
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