FDAnews
www.fdanews.com/articles/62015-intercell-reports-safety-results-of-encephalitis-vaccine-study

INTERCELL REPORTS SAFETY RESULTS OF ENCEPHALITIS VACCINE STUDY

August 25, 2006

Intercell announced that the safety analyses for the Phase III safety trial of its investigational Japanese encephalitis vaccine are positive. The trial was conducted at 39 study sites in Austria, Germany, Romania, Israel, Australia, New Zealand and the U.S. and included 2,683 randomized subjects. The study was designed to analyze the safety and tolerability of Intercell's investigational vaccine in a double-blind, placebo-controlled study.

Major endpoints of this study were the frequency of adverse events in both test groups, as well as local tolerability findings in both groups. First analyses of this trial show that the vaccine was systemically and locally well-tolerated. Overall, the local tolerability and general safety profile appeared to be comparable with placebo.

The clinical trial program consists of several additional clinical trials including an immunogenicity trial, a single-shot trial and a co-vaccination trial for travelers, which are all expected to be completed by early 2007. To date, more than 4,800 of the anticipated 5,370 trial participants have been enrolled and vaccinated.

Japanese encephalitis, a mosquito-borne flaviviral infection, is the leading cause of childhood encephalitis and viral encephalitis in Asia.