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    Summary
    EudraCT Number:2024-000341-27
    Sponsor's Protocol Code Number:DEN-324
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2024-12-13
    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 number2024-000341-27
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled (Participants aged 18 to 60 years) and Open-Label (Participants aged 4 to 17 years), Phase 2/3 Trial to Evaluate the Immunogenicity and Safety of 2 doses of a Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Subcutaneously to Healthy Adults, Adolescents, and Children in Japan
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Dengue Tetravalent Vaccine (TDV) in Healthy Subjects in Japan
    A.4.1Sponsor's protocol code numberDEN-324
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/003/2024
    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-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 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 (TDV) (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 log10 plaque forming unit(s)
    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.3.9.4EV 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.3.9.4EV 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.3.9.4EV 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, 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 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 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 the immunogenicity of TDV in healthy adults, adolescents, and children at other specified timepoints.
    •To assess the safety profile of TDV administered as 2 doses given 3 months apart in healthy adults, adolescents, and children.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is aged greater than or equal to (>=) 4 to less than or equal
    to (<=) 60 years at the time of signing the informed consent/pediatric
    assent form.
    2. Subject is Japanese male or female.
    3. Subject is in good health at the time of entry into the trial as
    determined by medical history, physical examination (including vital
    signs) and clinical judgment of the investigator.
    4. Subject and/or the subjects legally acceptable representative (LAR)
    who have signed and dated a written, informed consent/pediatric
    assent form, and any required privacy authorization prior to the
    initiation of any trial procedures, and after the nature of the trial has
    been explained.
    5. Subject can comply with trial procedures and is available for the
    duration of follow-up.
    E.4Principal exclusion criteria
    1.Has contraindications, warnings and/or precautions applicable to vaccination with TDV as specified in investigator brochure (IB).
    2.Has known hypersensitivity or allergy to any of IMP components (including excipients of IMP).
    3.Has behavioral or cognitive impairment or psychiatric disease that, in opinion of investigator, may interfere with subject's ability to participate in trial.
    4.Has history of progressive or severe neurologic disorder, seizure disorder or neuroinflammatory disease (example, Guillain-Barré syndrome).
    5.Has clinically significant active infection (as assessed by the investigator) or body temperature greater than (>) 38.0 degree Celsius (>100.4 degree Fahrenheit) within 3 days of intended investigational
    medicinal product (IMP) administration on Day 1 (M0).
    6.Has an illness, or history of any illness that, in opinion of investigator, might interfere with results of trial or pose additional risk to subject due to involvement in this trial.
    7.Has known or suspected impairment/alteration of immune function,
    including:
    a.Chronic administration of oral and/or parenteral steroids at doses considered sufficiently immunosuppressive (example,>=2 milligram per kilogram (mg/kg) body weight/day prednisone/prednisolone [or equivalent] for >=14 consecutive days, or, >=20 mg/day prednisone/prednisolone [or equivalent] for >=14 consecutive days) within 60 days prior to Day 1 (M0)
    b.Receipt of blood, immunoglobulins, blood products, and/or plasma derivatives within 90 days 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.Reported or known symptomatic HIV infection or asymptomatic HIV infection when accompanied by evidence of impaired immune function
    f.Reported or known Hepatitis B and/or Hepatitis C virus infection
    g.Genetic immunodeficiency
    8.Has known or suspected abnormalities of splenic or thymic function.
    9.Has known bleeding diathesis or any condition that may be associated with prolonged bleeding time.
    10.Has serious chronic or progressive disease deemed to be preclusive to trial entry, that is, not medically stable according to judgment of
    investigator.
    11.Subject is participating in any clinical trial with another investigational product within 30 days prior to Day 1 (M0) or plans to participate in another clinical trial at any time during conduct of this trial.
    12.Has previously received a vaccination against flavivirus other than Japanese encephalitis (JE) (investigational or licensed).
    13.Who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (M0) or who are planning to receive any vaccine other than IMP within 28 days of IMP
    administration.
    14.Who received coronavirus vaccine within 14 days prior to Day 1 (M0).
    15.Who received vaccine authorized for emergency use within 28 days prior to Day 1 (M0).
    16.Who received any JE vaccines within 28 days prior to Day 1 (M0) or who are planning to receive any JE vaccines during the trial period.
    17.Previous participation in any clinical trial of dengue or other flavivirus candidate vaccine, except for subjects who received placebo in those trials.
    18.Subject with body mass index (BMI) greater than or equal to 35 kg/m^2 (=weight in kg/[height in square meters]) on Day 1 (M0).
    19.Who intends to travel to dengue endemic areas during trial period.
    20.Subject with documented or suspected disease caused by flavivirus and subjects with history of prolonged (>=1 year) habitation in a dengue endemic area.
    21.Subject with history of substance or alcohol abuse within past 2 years prior to Day 1 (M0).
    22.Female subjects who are pregnant (that is, positive or indeterminate pregnancy test) or breastfeeding.
    23.Females of childbearing potential who are sexually active and who have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1 (M0).
    a."Childbearing potential" is defined as status post onset of menarche and not meeting any of following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status
    after bilateral oophorectomy, or status after hysterectomy
    b."Acceptable contraceptive methods" are defined as one or more of the following: hormonal contraceptive, barrier method (condom or diaphragm) every time during intercourse, intrauterine device, monogamous relationship with a vasectomized partner. The partner must have been vasectomized for at least 6 months prior to subject's trial enrollment
    24.Females of “childbearing potential” or non-sterilized males, who refuse to use an “acceptable contraceptive method” up to 6 weeks post second IMP administration on Day 90 (M3). In addition, they must be advised not to donate ova or sperm during this period.
    25.A first degree relative is involved in conduct of this trial.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of Seropositive Subjects for Each of the 4 Dengue Virus Serotypes
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Day 120
    E.5.2Secondary end point(s)
    1. Percentage of Seropositive Subjects for Each of the 4 Dengue Virus Serotypes
    2. Geometric Mean Titers (GMT) of Neutralizing Antibodies by Microneutralization Test (MNT) For Each of the 4 Dengue Serotypes
    3. Percentage of Seropositive Subjects for Multiple (2, 3, or 4) Dengue Virus Serotypes
    4. Number of Subjects with Solicited Local (Injection Site) Adverse Events (AEs)
    5. Number of Subjects with Solicited Local (Injection Site) AEs by Severity
    6.Number of Subjects with Solicited Systemic AEs
    7. Number of Subjects with Solicited Systemic AEs by Severity
    8. Percentage of Subjects with any Unsolicited AEs
    9. Percentage of Subjects with Serious Adverse Event (SAE)
    10. Percentage of Subjects with Medically Attended AEs (MAAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, Day 30, Day 90 and Day 270 (For Percentage of Seropositive Subjects for Each of the 4 Dengue Virus Serotypes); Day 1, Day 30, Day 90, Day 120 and Day 270 (For GMT of Neutralizing Antibodies and Percentage of Seropositive Subjects for Multiple [2, 3, or 4] Dengue Virus Serotypes);
    For 7 days post-vaccination at Day 1 and Day 90 for Solicited Local AEs and Solicited Local AEs by Severity; For 14 days post-vaccination at Day 1 and Day 90 for Solicited Systemic AEs and Solicited Systemic AEs by Severity;
    For 28 days Post-vaccination at Day 1 and Day 90 for Unsolicited AEs;
    From vaccination (Day 1) to End of Trial (Day 270) for SAEs and MAAEs
    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 trial3
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    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
    Japan
    E.8.7Trial has a data monitoring committee No
    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: 10
    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: 7
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 3
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 176
    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
    Being pediatric age group, subjects 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 186
    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: Japan
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    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
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