A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX

Summary

The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.

Timeline

Start

2005-11

Primary completion

2006-06

Completion

2006-11

Outcome

Met primary endpoint

paper Seroconversion after a single JE-CV vaccination (99.1%) was statistically non-inferior to that after three-dose MBD-JE (95.1%) vaccination. PMID 20934459 ↗

Publications

• Torresi J, McCarthy K, Feroldi E, Meric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials. Vaccine. 2010 Nov 23;28(50):7993-8000. doi: 10.1016/j.vaccine.2010.09.035. Epub 2010 Oct 8.

Drugs

Indications