Encephalitis

Regulatory approval to start pediatric clinical trials for Japanese Encephalitis (JE) Vaccine in India

Published in Drug Week, April 27th, 2007

Intercell AG and its partner Biological E. Ltd. (Hyderabad, India) announced today that the companies have obtained regulatory clearance to start a pediatric Phase II clinical trial for Intercell's novel Japanese Encephalitis Vaccine in India.

The randomized and controlled study aims to demonstrate the dose, safety and immunogenicity of Intercell's JE vaccine compared to a locally produced mouse-brain Japanese Encephalitis vaccine. The study, which will start in late April/early May, will enroll children at the age of one to three years. It is the first step towards the licensure of a new cell culture derived product in Asia, which is expected for late 2008/early 2009....

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Source: Drug Week (2007-04-27)

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