Austrian biotechnology firm Intercell AG says that the initial analysis of data form a Phase III trial of its Japanese encephalitis virus vaccine shows that the agent had met its primary endpoint in terms of both antibody concentration and seroconversion rate. The study was designed to compare the immunogenecity of Intercell's vaccine with Sanofi Pasteur's JE-VAX product, and was conducted at sites in the USA, Austria and Germany.
The full assessment program comprises several clinical studies which examine the vaccine's efficacy as both a single dose and as a co-vaccination for travellers, in addition to establishing its safety and tolerability. Intercell said that it expects all the clinical work to be completed early in 2007, adding that it would present further data at the annual meeting of the American Society of Tropical Medicine and Hygiene, which will take place in Atlanta, USA, later this year.
The Vienna-headquartered company also said that it had begun preparing for the submission of a Biologics License Application to the US Food and Drug Administration.
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