NCT06579755

A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled (Older Adults, Aged >60 to 79 Years) and Open-Label (Adults, Aged 45 to 60 Years), Multicenter Trial to Investigate the Safety and Immunogenicity of a Dengue Tetravalent Vaccine (TDV) Administered Subcutaneously to Adults and Older Adults With or Without Comorbidities in Endemic Areas for Dengue

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 45 Years – 79 Years
• Healthy volunteers: Accepted

Summary

Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. Researchers have seen that dengue fever now also happens more often in elderly persons. The main aim of this study is to learn more about the side effects of TDV in adult (45 - 60 years) and elderly (60 - 79 years) persons and about TDV's ability to create an immune response in adult and elderly persons. Another aim is to learn about the side effects of TDV in adult and elderly persons in endemic countries who have one or more additional medical conditions (called comorbidities) such as diabetes mellitus, hypertension or a chronic kidney condition. 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.

Conditions

• Dengue Fever

Interventions

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

Timeline

• Start date: 2026-01-20
• Primary completion: 2027-04-14
• Completion: 2027-04-14
• First posted: 2024-08-30
• Last updated: 2026-02-09

Locations

7 sites across 4 countries: Argentina, Brazil, Singapore, Thailand