NCT02492165

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Months – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)	0.5 mL, Subcutaneous
BIOLOGICAL	Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)	0.5 mL, Subcutaneous
BIOLOGICAL	Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)	0.5 mL, Subcutaneous
BIOLOGICAL	Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)	0.5 mL, Subcutaneous

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-03-01
• Completion: 2016-06-01
• First posted: 2015-07-08
• Last updated: 2022-03-28
• Results posted: 2016-11-29

Locations

1 site across 1 country: Vietnam