NCT00441259

Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age

Randomised, Double Blind, Controlled, Safety, Tolerability and Immunogenicity Phase II Trial of ChimeriVax™-JE and Japanese Encephalitis Inactivated Mouse Brain Vaccine in Children of Descending Age.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 9 Months – 10 Years
• Healthy volunteers: Accepted

Summary

This randomised, double-blind study is to be conducted on 96 subjects at multiple sites in India. Subjects will be enrolled by age group and randomised to either ChimeriVax™-JE (JE-CV) or JE Mouse Brain Derived Vaccine (JE-MBDV). Study consists of a screening period, a treatment period and a 2 year follow-up period. Primary safety endpoints will be the adverse event (AE) rates 28 days after completion of vaccination course. The primary efficacy endpoints will be the rate of seroconversion 28 days after completing vaccination.

Conditions

• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	ChimeriVax™-JE	One dose of 4.0 log10 PFU is given in a volume of 1 ml for children aged \> 3 years and 0.5 ml to children and infants aged \< 3 years administered subcutaneously
BIOLOGICAL	Japanese Encephalitis Inactivated Mouse Brain Vaccine	Two doses of 1 ml reconstituted JE-MBDV is given to subjects aged \> 3 years and 0.5 ml is given to children and infants aged \< 3 years administered subcutaneously

Timeline

• Start date: 2007-01-01
• Primary completion: 2011-02-01
• Completion: 2011-12-01
• First posted: 2007-02-28
• Last updated: 2012-08-27
• Results posted: 2012-08-27

Locations

3 sites across 1 country: India