Intercell Announces Positive Results from Two Clinical Phase III Studies
Product News Feb 03, 2012
Intercell AG has announced the successful completion of a pivotal Phase III trial in 1869 children conducted in the Philippines and favorable interim data from a second Phase III trial in EU, US and Australia.
Analysis of both studies showed that the vaccine was well tolerated and immunogenic in children aged 2 months to <18 years.
Based on these data, Intercell will submit applications for the approval of an IXIARO®/JESPECT® pediatric label extension to major regulatory agencies in Q2 2012.
The pivotal study in the Philippines was designed as a safety, immunogenicity and dose confirmation trial. The multi-center, randomized and active-controlled study enrolled 1,869 children aged 2 months to <18 years.
1,411 children received IXIARO®/JESPECT® at doses of either 0.25 ml / 3µg (half of an adult dose, ages below 3 years) or 0.5ml / 6µg (full adult dose, ages 12 years and older).
For ages 3 to <12 years the full adult dose was found appropriate in a dose-confirmation component of the trial. In the control group, 64 children received Prevnar® and 394 children received Havrix®.
In this pivotal study, the safety profile with overall adverse event rate up to Day 56 of 84.0% (<1 year) and 62.0% (≥1 year) was comparable to the control vaccines Prevnar® (87.5%, <1 year) and Havrix® (59.6%, ≥1 year).
The second study is an ongoing multi-center, open label, single arm trial in which 100 children from US, EU and Australia who are travelling to JEV-endemic areas are planned to receive IXIARO®/JESPECT®. The overall adverse event rate up to Day 56 in the interim analysis was 66.7%.
In both studies, more than 99% of children who received the appropriate dose of IXIARO®/JESPECT® achieved neutralizing antibody titers above the WHO-recognized protective titer.
"We are very pleased about the positive pivotal data in support of our label extension to protect also traveling children against Japanese Encephalitis - a key element of the further growth for Intercell’s first commercial product", states Thomas Lingelbach, Chief Executive Officer of Intercell AG.
Following the approval and launch of Intercell's vaccine against Japanese Encephalitis for adult travelers and military personnel in Europe, the United States, Canada, Hong Kong (IXIARO®) and Australia (JESPECT®), the development of a vaccine to protect children traveling to endemic areas from Japanese Encephalitis has been a major goal of the Company.
The vaccine is manufactured by Intercell AG’s wholly-owned subsidiary Intercell Biomedical Ltd. at our cGMP facility in Livingston, Scotland. The pediatric approval is expected by the end of 2012 or beginning of 2013.