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.
ʺWe 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 productʺ, states Thomas Lingelbach, Chief Executive Officer of Intercell AG.
Following the approval and launch of Intercellʹs 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.
About Japanese Encephalitis
Japanese Encephalitis (JE) is a deadly infectious disease found mainly in Asia. Approximately 30,000 to 50,000 cases of JE are reported in Asia each year, and the actual number of cases is likely much higher due to underreporting in rural areas. JE is fatal in approximately 30 percent of those who show symptoms and leaves half of survivors with permanent brain damage. The disease is endemic in Southeast Asia, a region with more than 3 billion inhabitants. Only within 1 month in the year 2005, Japanese Encephalitis killed more than 1,200 children during an epidemic outbreak in Uttar Pradesh, India, and Nepal.
Intercellʹs Japanese Encephalitis vaccine is a purified, inactivated vaccine for active immunization of adults against the Japanese Encephalitis virus. The total development time of this vaccine was more than 10 years. The vaccine was developed under a Collaborative Research and Development Agreement with the Walter Reed Army Institute of Research, a biomedical research laboratory of the U.S. Department of Defense.
Intercellʹs Phase III trials for the approval of the vaccine in adults found that the vaccine demonstrated excellent immunogenicity against Japanese Encephalitis and an overall clinical safety profile similar to the control arm, combined with an excellent local tolerability profile. These data were published in The Lancet in December 2007:
» The immunogenicity was comparable to that of the U.S. licensed product, JE-VAX®.
» Intercellʹs vaccine demonstrated an overall clinical safety profile similar to the control arm.
Further, Intercellʹs Japanese Encephalitis vaccine had a more favorable local tolerability profile in the head‐to‐head study with JE-VAX®.
Please refer to the Product / Prescribing information (PI) / Medication Guide approved in your respective countries for complete information including safety about this vaccine and details for reporting adverse events or inadvertent use in pregnant women/nursing mothers.
Important Safety Information
IXIARO®/JESPECT® is not indicated for use in persons below 18 years of age (below 17 years in the USA).
You should not receive this vaccine if you have had an allergic reaction to IXIARO®/JESPECT®. This vaccine contains protamine sulfate, which may cause allergic reactions in some people. Tell your doctor if you have had an allergic reaction to protamine sulfate before you receive this vaccine. After you are vaccinated, tell your doctor if you have any of the following problems because these may be signs of an allergic reaction: difficulty breathing, hoarseness or wheezing, hives, dizziness, weakness, or fast heartbeat.
IXIARO®/JESPECT® may not fully protect everyone who gets the vaccine. IXIARO®/JESPECT® does not protect against encephalitis caused by other viruses/pathogens. IXIARO®/JESPECT® does not protect against other diseases transmitted by mosquitoes. This vaccine is given in 2 doses. Dose 2 is scheduled 28 days after Dose 1. Make sure you receive both doses. It is very important that you receive the 2nd dose of the vaccine at least 7 days before potential exposure to the virus. If you had been previously vaccinated with IXIARO®/JESPECT®, consult with your doctor if you need a booster dose.
Make sure your doctor knows if you have a weakened immune system or are using medicines that may weaken the immune system. Tell your doctor if you are pregnant.