drugset / Trial / NCT00441259
Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2007-01
- Primary completion
- 2011-02
- Completion
- 2011-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ChimeriVax™-JE | Vaccine | 4 unknown | Subcutaneous |
| Comparator | Japanese Encephalitis Inactivated Mouse Brain Vaccine | Vaccine | 0.5 ml | Subcutaneous |
| Comparator | Japanese Encephalitis Inactivated Mouse Brain Vaccine | Vaccine | 1 ml | Subcutaneous |