Intercell announces start of pivotal Phase II/III study in India for vaccine to protect children from Japanese Encephalitis
- First pivotal Phase II/III trial in endemic region towards licensure of a novel pediatric vaccine to prevent Japanese Encephalitis (JE), manufactured by Intercell's partner, Biological E.
- Important development step towards a modern, cell culture-derived product in endemic countries - first country approval expected for end 2011
Vienna (Austria)/Hyderabad (India), February 21, 2011 - Intercell AG and its partner Biological E. Ltd. today announced the start of a pediatric Phase II/III study for the vaccine to protect children from Japanese Encephalitis. The vaccine is manufactured in India by Biological E. and is based on Intercell's technology, which was successfully used to gain product licensure of the adult vaccine in Europe, the United States, Canada and Hong Kong (IXIARO®) as well as in Australia (JESPECT®).
This randomized and controlled study will be the first pivotal Phase II/III study in an endemic region towards licensure of the pediatric JE vaccine. The study will enroll healthy children aged one to below three years across multiple sites in India. This Phase II/III trial aims at investigating safety and immunogenicity compared to a licensed competitor Japanese Encephalitis vaccine.
"We are very pleased with the progress in our collaboration with Biological E. which undertakes the development of this vaccine to protect children living in endemic areas threatened by this terrible disease. The start of the current Phase II/III study is a major step towards making our modern cell culture-derived product available in Asia, and supports our global vision for our Japanese Encephalitis franchise", states Thomas Lingelbach, Chief Operating Officer of Intercell AG.
In 2005, Intercell and Biological E. signed a contract for the development, manufacturing, marketing and distribution in India and the Indian subcontinent of Intercell's Japanese Encephalitis vaccine. The vaccine's further regulatory approval route for other Asian territories is expected through the World Health Organization - Novartis will be responsible for the marketing and distribution in these regions.
Vijay Kumar Datla, Chairman and Managing Director of Biological E. Ltd., added: "The start of this pivotal Phase II/III study is a significant milestone in our program. We hope to make the product available at the earliest possible time in order to best protect the vulnerable population living in JE-endemic regions."
Data from a previous Phase II study conducted in 2007 in India by Biological E. with vaccine manufactured at Intercell's Scottish manufacturing site suggested that the vaccine has a comparable excellent immunogenicity and safety profile in young children (one to below three years of age) as in adults, even if only half of the adult dose is applied.
In 2010, Biological E. conducted a trial in 20 healthy adults, confirming the safety profile seen in that previous Phase II trial with product manufactured at Biological E.'s facility.
Following the approval and launch of Intercell's vaccine against Japanese Encephalitis for adult travelers and military personnel in Europe, the USA and Australia, the development of a vaccine to protect children in endemic areas from Japanese Encephalitis has been a major goal of the Company.