Intercell AG (INRLY.PK) Wednesday said that it has successfully completed a Phase III trial in 1869 children conducted in Philippines for pediatric label extension of the company's Japanese Encephalitis, or JE, vaccine. It also noted that the interim data from a second Phase III trial in EU, US and Australia has been favorable.
The vaccine for encephalitis, an acute inflammation of the brain, is already available in the market for adults. The company is trying to extend its usage to children traveling to endemic areas.
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 below18 years. Out of these children, 1411 received IXIARO/JESPECT, while in the remaining control group, 64 children received Prevnar and 394 children received Havrix.
The company said that in this pivotal study, the safety profile with overall adverse event rate up to Day 56 was 84.0 percent, in children less than 1 year, and 62.0 percent, in children of age 1 and above. This was comparable to the control vaccines Prevnar, whose adverse rate was 87.5 percent in children less than 1 year, and Havrix , whose adverse rate was 59.6 percent in children of age 1 and above.
The second study is an ongoing multi-center, open label, single arm trial in which 100 children from US, EU and Australia who are traveling to JEV-endemic areas are planned to receive IXIARO/JESPECT. The company noted that overall adverse event rate up to Day 56 in the interim analysis was 66.7 percent.
In both studies, more than 99 percent of the children who received the appropriate dose of IXIARO/JESPECT achieved neutralizing antibody titers above the World Health Organiation-recognized protective titer.
Intercell plans to submit applications for the approval of an IXIARO/JESPECT pediatric label extension to major regulatory agencies in the second quarter of 2012.The approval is expected by the end of 2012 or beginning of 2013.
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