drugset / Trial / NCT00981630
Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2004-11
- Primary completion
- 2006-02
- Completion
- 2007-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ChimeriVax™-Japanese Encephalitis Vaccine | Vaccine | 3 unknown | Subcutaneous |
| Subject | ChimeriVax™-Japanese Encephalitis Vaccine | Vaccine | 4 unknown | Subcutaneous |
| Subject | ChimeriVax™-Japanese Encephalitis Vaccine | Vaccine | 5 unknown | Subcutaneous |