Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.

The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.

This is a randomized, controlled, multi-center, double blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.

624 subjects will be enrolled at approximately 6 sites in study centers in Austria and Germany.

Main Inclusion Criteria:

• Male and female subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test

Main Exclusion Criteria:

• History of immunodeficiency or immunosuppressive therapy, known HIV, drug addiction including alcohol dependence