NCT06741683

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 4 Years – 60 Years
• Healthy volunteers: Accepted

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).

Conditions

• Dengue Fever

Interventions

Type	Name	Description
BIOLOGICAL	TDV	TDV SC injection.
OTHER	Placebo	Placebo SC injection.

Timeline

• Start date: 2025-01-31
• Primary completion: 2025-07-09
• Completion: 2025-12-17
• First posted: 2024-12-19
• Last updated: 2025-12-30

Locations

5 sites across 1 country: Japan