Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects

Summary

The purpose of this study is to describe the immunogenicity and safety of IMOJEV® in adult and pediatric populations in Vietnam and serve a bridging study to compare immunogenicity, reactogenicity, and safety data obtained with IMOJEV® in the Vietnamese population with data from other Asian pediatric populations. Primary objective: \- To describe the safety profile of a single dose of IMOJEV®. Secondary objectives: * To evaluate the immune response to JE 28 days after the administration of a single dose of IMOJEV® in healthy Vietnamese subjects aged from 9 months to 60 years.

Timeline

Start

2015-06

Primary completion

2016-03

Completion

2016-06

Publications

• Vu TD, Nguyen QD, Tran HTA, Bosch-Castells V, Zocchetti C, Houillon G. Immunogenicity and safety of a single dose of a live attenuated Japanese encephalitis chimeric virus vaccine in Vietnam: A single-arm, single-center study. Int J Infect Dis. 2018 Jan;66:137-142. doi: 10.1016/j.ijid.2017.10.010. Epub 2017 Nov 27.

Drugs

Indications