Intercell to expand applications for JE vaccine
Vienna – Austrian vaccine specialist Intercell AG is to expand the label of its vaccine Ixiaro/JEspect for Japanese encephalitis (JE). On Monday the company announced the start of a clinical phase III study for the travel diarrhoea vaccine in 100 children over two months of age. The vaccine is currently licensed as an adult vaccine in Europe, Canada, the United States (Ixiaro) and Australia (JEspect). In the US, the vaccine is licensed for those above 17 years of age, and in Europe, Canada and Australia it is licensed for those above 18 years of age. The study will investigate the safety and immunogenicity of the vaccine. A phase II study conducted in 2007 comprising children aged one to three years of age by Intercell's partner Biological E (Hyderabad, India) suggested that in young children the vaccine has a comparable immunogenicity and safety profile to that of adults, even if only half of the adult dose is administered. A second phase III study will be conducted as a pivotal trial in an endemic region, such as the Philippines and Malaysia. This multi-centre study will include 1,859 children, of whom 1,401 will receive the vaccine. The study will evaluate the safety profile of the vaccine compared to HAVRIX®720 and Prevnar®. In addition, immunogenicity will be studied in a subgroup of children, and Intercell aims to confirm the vaccine dose for ages three to below 12 years. The further development of the vaccine to protect children travelling to endemic areas from Japanese Encephalitis has been a major goal of the company following the approval and launch of Intercell's vaccine against Japanese Encephalitis for adult travellers and military personnel in Europe, Canada, the USA and Australia.