Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults

Summary

The purpose of this study is to evaluate the safety and immune response of a naturally aged lot of tetravalent dengue vaccine (TDV) in healthy participants, aged 18 to 60 years, in non-endemic country(ies) for dengue.

Timeline

Start

2019-03-28

Primary completion

2019-10-14

Completion

2020-03-13

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.
• Patel SS, Winkle P, Faccin A, Nordio F, LeFevre I, Tsoukas CG. An open-label, Phase 3 trial of TAK-003, a live attenuated dengue tetravalent vaccine, in healthy US adults: immunogenicity and safety when administered during the second half of a 24-month shelf-life. Hum Vaccin Immunother. 2023 Aug;19(2):2254964. doi: 10.1080/21645515.2023.2254964. Epub 2023 Oct 17.

Drugs

Indications