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news.Intercell and its partner Biological E. have obtained regulatory clearance to start a pediatric phase II clinical trial for the Japanese encephalitis vaccine in India.
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The study aims to demonstrate the dose, safety and immunogenicity of Intercell’s JE vaccine compared to a locally produced mouse-brain Japanese encephalitis vaccine. It is the first step towards the licensure of a new cell culture derived product in Asia, which is expected for late 2008 or early 2009.
“We have clearly defined a straight forward development process for our Japanese encephalitis vaccine to enter endemic markets. It is our priority to make the vaccine, which is based on proven and safe technology, also available for the population and especially the children in endemic regions”, states Gerd Zettlmeissl, CEO of Intercell.
In previous phase III trials, Intercell’s Japanese encephalitis vaccine has demonstrated a favorable safety and immunogenicity profile. Novartis owns the marketing and distribution rights for Intercell’s Japanese encephalitis virus vaccine in the United States, Europe and certain other markets in Asia and Latin America.