Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV)

Summary

The purpose of this study is to evaluate the equivalence of the lyophilized formulation of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of TDV.

Timeline

Start

2014-08-06

Primary completion

2015-05-19

Completion

2015-05-19

Outcome

Missed primary endpoint

paper The primary endpoint was not met, because immunologic equivalence after one dose was only shown for the DENV-2 serotype. PMID 32119591 ↗

Publications

• 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.
• Turner M, Papadimitriou A, Winkle P, Segall N, Levin M, Doust M, Johnson C, Lucksinger G, Fierro C, Pickrell P, Raanan M, Tricou V, Borkowski A, Wallace D. Immunogenicity and safety of lyophilized and liquid dengue tetravalent vaccine candidate formulations in healthy adults: a randomized, phase 2 clinical trial. Hum Vaccin Immunother. 2020 Oct 2;16(10):2456-2464. doi: 10.1080/21645515.2020.1727697. Epub 2020 Mar 2.

Drugs

Indications