Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Co-administered With an Hepatitis A Virus Vaccine

Phase 3 Completed 900 enrolled Takeda

RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to investigate the immunogenicity and safety of the concomitant administration of TDV (subcutaneous \[SC\] injection) and of hepatitis A virus (HAV) vaccine (intramuscular \[IM\] injection) in healthy participants aged 18 to 60 years living in country(ies) non-endemic for both dengue and hepatitis.

Timeline

Start: 2018-05-16
Primary completion: 2018-10-03
Completion: 2019-07-09

Publications

Tricou V, Eyre S, Ramjee M, Collini P, Mojares Z, Loeliger E, Mandaric S, Rauscher M, Brose M, Lefevre I, Folschweiller N, Wallace D. A randomized phase 3 trial of the immunogenicity and safety of coadministration of a live-attenuated tetravalent dengue vaccine (TAK-003) and an inactivated hepatitis a (HAV) virus vaccine in a dengue non-endemic country. Vaccine. 2023 Feb 10;41(7):1398-1407. doi: 10.1016/j.vaccine.2023.01.007. Epub 2023 Jan 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Havrix	Vaccine	1 ml	Intramuscular
Subject	TAK-003	Vaccine	0.5 ml	Subcutaneous

Indications

No indication recorded.