drugset / Trial / NCT07047521

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

NCT07047521

Phase 3 Active not recruiting 496 enrolled Takeda
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-11-07
Primary completion
2026-06-29
Completion
2026-12-22

Drugs

EvaluationDrugModalityDoseRoute
Subject DENGUE VIRUS, LIVE ATTENUATED Vaccine 0.5 ml Subcutaneous

Indications