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

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.

NCT Number	NCT07047521
Lead Sponsor	Takeda
Conditions	Dengue Fever
Enrollment	496 participants
Start Date	2025-11-07
Primary Completion	2026-06-29 (estimated)
Study Completion	2026-12-22 (estimated)
Updated on ClinicalTrials.gov	2026-07-17