AzTrials
AzTrials

Dengue FeverPhase 2/3NCT06741683

A Study of Dengue Tetravalent Vaccine (TDV) in Healthy Participants in Japan

A Phase 2/3 study testing TDV in people with Dengue Fever, run by Takeda at 5 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Dengue fever is caused by an infection with the dengue virus. Vaccination with TDV can help prevent dengue fever. The main purpose of this study is to learn about TDV's ability to create an immune response in adults, adolescents, and children administered. Read more about this study

Who is it for?
Ages 4 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Dengue Fever
What is being tested?
TDV
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
187 participants
Where
5 sitesJapan
Study dates
31 Jan 2025to 17 Dec 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Participant aged >=4 to less than or equal to (<=) 60 years at the time of signing the informed consent/pediatric assent form.
  • Participant is Japanese male or female.
  • Participant 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.
  • Participant and/or the participant's 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.
  • Participant can comply with trial procedures and is available for the duration of follow-up.

Who cannot join

  • Participant has contraindication(s), warning(s), and/or precaution(s) applicable to vaccination with TDV as specified in the Investigator's Brochure.
  • Participant has a known hypersensitivity or allergy to any of the IMP components (including excipients of the IMP).
  • 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.
  • Participant has a history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (example, Guillain-Barré syndrome).
  • 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 (Month [M] 0).
  • Note: In principle, oral temperature should be measured for body temperature. In cases where it is difficult to measure oral temperature, such as in young children, underarm (axillary) temperature may be used instead.
Show all 39Show fewer
  • 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.
  • Participant has a known or suspected impairment/alteration of immune function, including:
  • Chronic administration of oral and/or parenteral steroids at doses considered sufficiently immunosuppressive (example, >=2 milligram per kilogram [mg/kg] body weight prednisone [or equivalent] for >=14 consecutive days, or >=20 milligram per day [mg/day] prednisone [or equivalent] administered for >=14 consecutive days) within 60 days prior to Day 1 (M0), Note: use of corticosteroids by inhaled, intranasal, intra-articular, bursal, tendon injection, or topical routes is allowed.
  • Receipt of blood, immunoglobulins, blood products, and/or plasma derivatives within the 90 days prior to Day 1 (M0).
  • Receipt of immunostimulants within 60 days prior to Day 1 (M0).
  • Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (M0).
  • Reported or known symptomatic HIV infection or asymptomatic HIV infection when accompanied by evidence of impaired immune function.
  • Reported or known Hepatitis B and/or Hepatitis C virus infection.
  • Genetic immunodeficiency.
  • Participant has known or suspected abnormalities of splenic or thymic function.
  • Participant has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
  • 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.
  • Participant 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 the conduct of this trial.
  • Participant has previously received a vaccination against flavivirus other than Japanese encephalitis (JE) (investigational or licensed).
  • Participant 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.
  • Participant who received a coronavirus vaccine within 14 days prior to Day 1 (M0).
  • Participant who received a vaccine authorized for emergency use within 28 days prior to Day 1 (M0).
  • Participant 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.
  • Previous participation in any clinical trial of a dengue or other flavivirus candidate vaccine, except for participants who received placebo in those trials.
  • Participant with body mass index (BMI) >=35 kilograms per square meter (kg/m^2) on Day 1 (M0).
  • Participant who intends to travel to dengue endemic areas during the trial period.
  • Participant with documented or suspected disease caused by a flavivirus and participants with a history of prolonged (>=1 year) habitation in a dengue endemic area.
  • Participant with history of substance or alcohol abuse within the past 2 years prior to Day 1 (M0).
  • Female participants who are pregnant (that is, a positive or indeterminate pregnancy test) or breastfeeding.
  • 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).
  • "Childbearing potential" is defined as status post onset of menarche and not meeting any of the 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.
  • 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 the participant's trial enrollment.
  • 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.
  • A first degree relative is involved in the conduct of this trial.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Japan5 sites

  • PS Clinic

    Fukuoka, Fukuoka

  • Saitama City Hospital

    Saitama-shi, Saitama

  • Sumida Hospital

    Sumida-ku, Tokyo

  • Tamura Clinic

    Tokyo

  • OKURA Otolaryngology Clinic

    Toshima-ku, Tokyo

Other trials in Japan

About this study

Official title: 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

Dengue fever is caused by an infection with the dengue virus. Vaccination with TDV can help prevent dengue fever.

The main purpose of this study is to learn about TDV's ability to create an immune response in adults, adolescents, and children administered. In this study, participants will receive 2 vaccinations with TDV (the second 3 months after the first). During the study, participants will visit their study clinic 5 times.

Participants will be in this study for approximately 270 days (9 months).

Conditions
Dengue Fever
Being tested
TDV, Placebo
Medical subject headings
Dengue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TDVBiological

    Also called TAK-003

    TDV SC injection.

  • PlaceboOther

    Also called Placebo SC injection.

    Placebo SC injection.

Study groups in NCT06741683
Study groupRoleWhat they receive
Cohort 1: TDV 0.5 mLExperimentalParticipants with the age group 18 to 60 years will receive TDV, 0.5 milliliter (mL) subcutaneous (SC) injections, on Day 1 and Day 90.
Receives: Biological: TDV
Cohort 1: PlaceboPlacebo comparatorParticipants with the age group 18 to 60 years will receive placebo (normal saline), 0.5 mL SC injections, on Day 1 and Day 90.
Receives: Other: Placebo
Cohort 2: TDV 0.5 mLExperimentalParticipants with the age group 4 to 17 years will receive TDV, 0.5 mL SC injections, on Day 1 and Day 90.
Receives: Biological: TDV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Seropositive Participants for Each of the 4 Dengue Virus Serotypes on Day 120

    Seropositivity is defined as a reciprocal neutralizing titer greater than or equal to (>=) 10. The 4 dengue virus serotypes (DENV) are DENV-1, DENV-2, DENV-3 and DENV-4.

    Measured: Day 120

Secondary outcomes (10)

  1. Percentage of Seropositive Participants for Each of the 4 Dengue Virus Serotypes on Day 1, Day 30, Day 90 and Day 270

    Seropositivity is defined as a reciprocal neutralizing titer >=10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.

    Measured: Day 1, Day 30, Day 90 and Day 270

  2. Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Virus Serotypes on Day 1, Day 30, Day 90, Day 120 and Day 270

    GMTs of neutralizing antibodies will be measured by microneutralization Test (MNT) for each of the 4 Dengue serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.

    Measured: Day 1, Day 30, Day 90, Day 120 and Day 270

  3. Percentage of Seropositive Participants for Multiple (2, 3, or 4) Dengue Serotypes on Day 1, Day 30, Day 90, Day 120 and Day 270

    Seropositivity is defined as a reciprocal neutralizing titer >=10 for multiple dengue serotypes (2, 3, or 4).

    Measured: Day 1, Day 30, Day 90, Day 120 and Day 270

  4. Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 days After Vaccination at Day 1 and Day 90

    The solicited local (at injection site) AEs includes pain, erythema, and swelling.

    Measured: For 7 days after vaccination at Day 1 and Day 90

  5. Number of Participants with Solicited Local (Injection Site) AEs by Severity for 7 days After Vaccination at Day 1 and Day 90

    The solicited local (at injection site) AEs includes pain, erythema, and swelling. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.

    Measured: For 7 days after vaccination at Day 1 and Day 90

  6. Number of Participants With Solicited Systemic AEs for 14 days After Vaccination at Day 1 and Day 90

    The solicited systemic AEs for less than (<) 6 years of age will be fever, irritability/fussiness, drowsiness, and loss of appetite; and for >=6 years of age will be asthenia, fever, headache, malaise, and myalgia.

    Measured: For 14 days after vaccination at Day 1 and Day 90

  7. Number of Participants With Solicited Systemic AEs by Severity for 14 days After Vaccination at Day 1 and Day 90

    The solicited systemic AEs for <6 years of age will be fever, irritability/fussiness, drowsiness, and loss of appetite; and for >=6 years of age will be asthenia, fever, headache, malaise, and myalgia. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.

    Measured: For 14 days after vaccination at Day 1 and Day 90

  8. Percentage of Participants With Any Unsolicited AEs for 28 days After Vaccination at Day 1 and Day 90

    An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day of Investigational Medicinal Product [IMP] administration).

    Measured: For 28 days after vaccination at Day 1 and Day 90

  9. Percentage of Participants With Serious Adverse Event (SAE)

    A SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event.

    Measured: From first vaccination on Day 1 through the end of trial (up to Day 270)

  10. Percentage of Participants With Medically Attended AEs (MAAEs)

    MAAEs are defined as AEs leading to an unscheduled visit or by a healthcare professional including visits to an emergency department (medically attended visits), but not fulfilling seriousness criteria.

    Measured: From first vaccination on Day 1 through the end of trial (up to Day 270)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2024
  2. Study start31 Jan 2025
  3. Primary completion9 Jul 2025
  4. Study completion17 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06741683
Sponsor's protocol ID
DEN-324
Other IDs
2024-000341-27, jRCT2071240088
Status last verified
Dec 2025
First submitted
15 Dec 2024
Last updated
30 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing TDV in people with Dengue Fever, run by Takeda at 5 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Seropositive Participants for Each of the 4 Dengue Virus Serotypes on Day 120 (time frame: Day 120). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06741683.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in