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Date: 2009-12-29
Phase: III
Anouncement: Launch
Biotech: Intercell (Austria)
Pharma:
Product: Ixiaro®/Jespect®
Disease: Japanese Encephalitis
Country: USA, Europe and Australia
Other: Intercell announced the initiation of a pediatric Phase III study for Ixiaro®/Jespect® in children above 6 months of age travelling from USA, Europe and Australia to JE endemic areas.
The vaccine is currently licensed as adult vaccine in Europe, Canada, the United States (Ixiaro®/) and Australia (Jespect®). In the U.S.,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.
This multinational study including 100 children will be the first of two Phase III trials in support of the Ixiaro®/Jespect® label extension for pediatric licensure for children above 2 months of age. The study will investigate safety and immunogenicity of the vaccine.

A second Phase III study will be conducted as a pivotal trial in an endemic region, namely, the
Philippines and Malaysia. This multi-center, randomized and controlled study will include
1,859 children of whom 1,401 will receive Ixiaro®/Jespect®. 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 the vaccine dose for ages three to below 12 years
will be confirmed.