NCT01092507

A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and Toddlers

A Controlled Study of the Immunogenicity and Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Comparison With SA14-14-2 Vaccine in Infants and Toddlers in Thailand

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Months – 18 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare a single dose of Japanese encephalitis (JE) chimeric virus vaccine (JE-CV) with a single dose of SA14-14-2 live vaccine as primary vaccination in infants and toddlers. Primary Objective: * To demonstrate the non-inferiority of the antibody response 28 days after vaccine administration of one dose of JE CV (administered on Day 0) compared to the antibody response after one dose of the SA14-14-2 control vaccine (administered on Day 0). Secondary Objectives: * To describe the immune response to JE in both vaccine groups in JE-CV virus and SA14-14-2 virus before and after a single dose of JE CV or a single dose of SA14-14-2 vaccine * To describe the safety profile in all vaccinated subjects up to 28 days and all serious adverse events (SAEs) up to 6 months after vaccination. * To describe only related SAEs and all death from 6 month to 12-month follow-up.

Detailed description

All participants will receive one injection of their randomized vaccine on Day 0. Follow-up will continue for 12 months after vaccination.

Conditions

• Encephalitis
• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	Japanese encephalitis chimeric virus vaccine (JE-CV)	0.5 mL, Subcutaneous
BIOLOGICAL	Japanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®)	0.5 mL, Subcutaneous

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-09-01
• Completion: 2011-10-01
• First posted: 2010-03-25
• Last updated: 2013-12-25
• Results posted: 2013-12-02

Locations

3 sites across 1 country: Thailand