Post-licensure Safety Study of IMOJEV® in Thailand

Summary

The aim of this study is to further characterize the safety profile of IMOJEV®. Primary Objective: * To describe serious adverse events (SAEs, including adverse events of special interest \[AESIs\]) up to 60 days after administration of one dose of IMOJEV®. Secondary Objective: * To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after administration of one dose of IMOJEV®.

Timeline

Start

2013-11

Primary completion

2015-04

Completion

2015-10

Publications

• Chotpitayasunondh T, Pruekprasert P, Puthanakit T, Pancharoen C, Tangsathapornpong A, Oberdorfer P, Kosalaraksa P, Prommalikit O, Tangkittithaworn S, Kerdpanich P, Techasaensiri C, Korejwo J, Chuenkitmongkol S, Houillon G. Post-licensure, phase IV, safety study of a live attenuated Japanese encephalitis recombinant vaccine in children in Thailand. Vaccine. 2017 Jan 5;35(2):299-304. doi: 10.1016/j.vaccine.2016.11.062. Epub 2016 Nov 28.

Drugs

Indications