NCT01396512

Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers

Immunogenicity and Safety of a Single Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) in Comparison With a Single Dose of SA14-14-2 Vaccine (CD.JEVAX™, Chengdu Institute of Biological Products, China) Administered in Healthy Toddlers in South-Korea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 12 Months – 24 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine \[CD.JEVAX™\]) after a single dose vaccination to support product registration. Primary Objective: * To demonstrate the non-inferiority of the antibody response 28 days after administration of one dose of IMOJEV™ compared to the antibody response 28 days after administration of one dose of the CD.JEVAX™ control vaccine. Secondary Objectives: * To describe the immune response to Japanese encephalitis (JE) in both vaccine groups using 50% plaque reduction neutralization assay (PRNT50) assays before and after a single dose of IMOJEV™ vaccine or a single dose of CD.JEVAX™ vaccine. * To describe the safety of vaccination in all subjects up to 28 days and all serious adverse events up to 6-month after vaccination.

Detailed description

All participants will receive a single dose of their assigned vaccination at Visit 1 (Day 0) and undergo immunogenicity assessment at Day 28 post-vaccination. Safety will be assessed from day of vaccination and up to 6 months post-vaccination.

Conditions

• Japanese Encephalitis
• Japanese Encephalitis Virus Disease

Interventions

Type	Name	Description
BIOLOGICAL	Live attenuated Japanese encephalitis chimeric virus vaccine	0.5 mL, Subcutaneous
BIOLOGICAL	Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine)	0.5 mL, Subcutaneous

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-03-01
• Completion: 2013-06-01
• First posted: 2011-07-18
• Last updated: 2014-04-25
• Results posted: 2014-04-25

Locations

6 sites across 1 country: South Korea