Date: 2011-02-21
Type of information:
phase: 2-3
Announcement:
Company: Intercell (Austria)
Product: cell culture-derived, pediatric vaccine to prevent Japanese Encephalitis
Action mechanism: vaccine
Disease: Japanese Encephalitis
Therapeutic area: Infectious diseases
Country: India
Trial details:
Latest
news: Intercell AG and its partner Biological E. Ltd. 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 (Ixiario®) 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.
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.
