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A Study of Dengue Tetravalent Vaccine (TDV) in Healthy Participants in Japan | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

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

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

NCT06741683•Takeda

View on ClinicalTrials.gov

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. 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).

Eligibility

Age

4 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Participant aged \>=4 to less than or equal to (\<=) 60 years at the time of signing the informed consent/pediatric assent form.
•2. Participant is Japanese 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 clinical judgment of the investigator.
•4. 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.
•5. Participant can comply with trial procedures and is available for the duration of follow-up.

Exclusion Criteria

•1. Participant has contraindication(s), warning(s), and/or precaution(s) applicable to vaccination with TDV as specified in the Investigator's Brochure.
•2. Participant has a known hypersensitivity or allergy to any of the IMP components (including excipients of the IMP).
•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 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.
•6. 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.
•7. Participant has a known or suspected impairment/alteration of immune function, including:
•1. 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.
•2. Receipt of blood, immunoglobulins, blood products, and/or plasma derivatives within the 90 days prior to Day 1 (M0).
+29 more criteria

Locations (5)

PS Clinic

Fukuoka, Fukuoka, Japan

Saitama City Hospital

Saitama-shi, Saitama, Japan

Sumida Hospital

Sumida-ku, Tokyo, Japan

OKURA Otolaryngology Clinic

Toshima-ku, Tokyo, Japan

Tamura Clinic

Tokyo, Japan

Key Dates

Start Date

January 31, 2025

Primary Completion Date

July 9, 2025

Completion Date

December 17, 2025

Last Updated

December 30, 2025

Enrollment

187

ACTUAL participants

Conditions

Dengue Fever

Interventions

TDV

BIOLOGICAL

Placebo

OTHER

Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection

NCT07007585

DengueDengue Fever+1 more

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RECRUITINGPHASE3

A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers

NCT06665035

Dengue Fever

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection

A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers

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