NCT07047521

A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults

A Randomized, Double-Blind, Phase 3 Trial to Investigate the Immunogenicity and Safety of a New Formulation of Tetravalent Dengue Vaccine (TDV) Versus the Current Formulation of TDV in Healthy Adults (Aged 18-60 Years) in a Non-Endemic Area for Dengue

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 496 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 60 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. The TDV in current formulation has been approved by health authorities in many countries around the world. The main aim of the study is to confirm that the TDV new formulation induces the similar immune response as approved TDV. Healthy adults who live in an area in which dengue fever does not occur will receive 2 TDV vaccinations 3-months apart with either the new or the current TDV. Blood samples will be taken before and after the vaccinations. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 5 times.

Conditions

• Dengue Fever

Interventions

Type	Name	Description
BIOLOGICAL	Tetravalent Dengue Vaccine (TDV)	TDV subcutaneous injection

Timeline

• Start date: 2025-11-07
• Primary completion: 2026-08-30
• Completion: 2027-07-30
• First posted: 2025-07-02
• Last updated: 2026-02-12

Locations

5 sites across 1 country: Australia