drugset / Trial / NCT03746015
Immunogenicity and Safety of Tetravalent Dengue Vaccine Candidate (TDV) in Flavivirus-Naïve and Dengue-Immune Adults
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to assess the neutralizing antibody response against each dengue serotype post-vaccination.
Timeline
- Start
- 2018-12-28
- Primary completion
- 2021-03-01
- Completion
- 2021-03-01
Publications
- Mandaric S, Friberg H, Gottardo R, Messer W, Tricou V, Faccin A, Roubinis N, Nadeem I, Gray L, Sharma M, Currier JR, Biswal S. Humoral and cellular responses to a tetravalent dengue vaccine (TAK-003) in adults from a dengue non-endemic region: An open-label phase 2 trial. Vaccine. 2026 Apr 2;77:128373. doi: 10.1016/j.vaccine.2026.128373. Epub 2026 Feb 20.
- Rauscher M, Youard Z, Faccin A, Patel SS, Pang H, Zent O. Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. Expert Rev Vaccines. 2025 Dec;24(1):221-229. doi: 10.1080/14760584.2025.2480297. Epub 2025 Mar 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tetravalent Dengue Vaccine Candidate | Unknown | 0.5 ml | Subcutaneous |