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

A Multicentre, Randomized, Double-blind, Phase III Study of The Comparative Immunogenicity, Safety and Tolerability of Two Japanese Encephalitis Vaccines (ChimeriVax™-JE and JE-VAX®)

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.

Inclusion Criteria:

• Subjects aged 18 or above
• Subjects in good general health.
• Females must have negative pregnancy test and be using adequate form of contraception

Exclusion Criteria:

• History of vaccination/infection with JE or Yellow fever or other flaviviruses
• History of residence/travel to flavivirus endemic regions
• History of anaphylaxis/serious adverse reactions
• Administration of vaccine within 30 days of study or during treatment period
• Clinically significant physical exam/medical history/lab abnormalities
• Pregnancy
• Excessive alcohol/drug abuse
• Hypersensitivity to constituents of JE-VAX®
• Blood transfusion/treatment with blood product within 6months of study and during study treatment period
• Known/suspected immunodeficiency
• Compromised blood brain barrier
• Employees of Clinical Research Organization (CRO)/study site staff
• Any other condition which would exclude subject.