Date: 2012-02-01
Type of information:
phase: 3
Announcement: completion of a pediatric study
interim data
Company: Intercell (Austria)
Product: Ixiaro®/Jespect®
Action mechanism:
Disease: Japanese encephalitis
Therapeutic area: Infectious diseases
Country: The Philippines, Australia, Europe, USA
Trial
details: 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. 1,411children received Ixiaro®/Jespect® at doses of either 0.25 ml / 3 microg (half of an adult dose, ages below 3 years) or 0.5ml : 6 microg (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% (greater than or equal to 1 year) was comparable to the control vaccines Prevnar® (87.5%, <1 year) and Havrix® (59.6%, greater than or equal to 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%.
Latest
news: Intercell has announced positive results from two clinical Phase III studies supporting pediatric label extension of Japanese encephalitis vaccine for children traveling to endemic areas. First, the company 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. 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. The pediatric approval is expected by the end of 2012 or beginning of 2013.
