Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00981630
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 2
Start date	November 2004
Completion date	November 2007

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