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

Japanese Encephalitis Clinical Trial

Official title:
Immunogenicity and Safety of a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Given to Healthy Subjects in Vietnam

Clinical Trial 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.

Clinical Trial Description

Study participants will be enrolled by age group and will each receive one injection of IMOJEV® on Day 0 given as primary vaccination. They will be assessed for immunogenicity and safety, post-vaccination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02492165
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date June 2015
Completion date June 2016
View Details
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