Austrian biotech major, Intercell and its partner Hyderabad-based Biological E. Ltd. announced that they 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.
Mr Gerd Zettlmeissl, Chief Executive Officer of Intercell, said, "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."
Mr Vijay Kumar Datla, Chairman and Managing Director of Biological E. Ltd said, "We believe that this is a very important milestone in our endeavor to bring a safe and efficacious vaccine to endemic regions."