NCT00981630

Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine

Randomised, Double-blind, Placebo Controlled Phase II, Dose-ranging Study of the Safety, Tolerability and Immunogenicity of Live Attenuated ChimeriVax™-JE Vaccine (Lyophilised)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 48 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability, and immunogenicity of a new formulation of lyophilised ChimeriVax™-JE, given at three dose levels, compared with placebo. Primary Objectives: Safety: * To obtain safety and tolerability data for a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels, in healthy adult volunteers (18-49 years old). Immunogenicity: * To obtain data on the antibody response to a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels, in healthy adult volunteers without prior Japanese encephalitis immunity. * To assess the durability of immune response up to 12 months following a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels.

Detailed description

All participants will received a single dose of study vaccine, ChimeriVax™-JE or placebo on Day 0. The double-blind treatment phase will last 30 days, with follow-up visits at 6 and 12 months.

Conditions

• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	Live attenuated Japanese encephalitis virus	0.5 mL,Subcutaneous
BIOLOGICAL	Live attenuated Japanese encephalitis virus	0.5 mL, Subcutaneous
BIOLOGICAL	Live attenuated Japanese encephalitis virus	0.5 mL, Subcutaneous
BIOLOGICAL	ChimeriVax™ diluent (Placebo)	0.5 mL, Subcutaneous

Timeline

• Start date: 2004-11-01
• Primary completion: 2006-02-01
• Completion: 2007-11-01
• First posted: 2009-09-22
• Last updated: 2012-12-05
• Results posted: 2012-12-05

Locations

2 sites across 1 country: Australia