RxTrials Institute Drug Pipeline Alert

Data from a pediatric Phase II study of Japanese encephalitis vaccine IC51, which is being produced by Austrian drugmaker Intercell and its India-based partner Biological E., showed the product has an excellent safety and immunogenicity profile, Intercell says.

The Japanese encephalitis virus is estimated to affect 50,000 people annually — mostly children younger than 10 years — and is endemic in Southeast Asia.

The study began in 2007 and enrolled 60 healthy children ages 1–3. The seroconversion rate of the test vaccine in the 3-microgram dose group was 96 percent, which was comparable to the rates observed in adults in previous Phase III trials.

The results support Intercell’s development plan for endemic regions and pave the way for late-stage development and licensure in late 2009 or early 2010, the company said.