Analysis of the pivotal Phase III safety and immunogenicity data showed positive results and that the study met its primary endpoint.
The clinical study was designed to compare the immunogenicity and safety of Biological E’s investigational cell culture‐derived vaccine with the mouse brain derived vaccine produced by the Korean Green Cross Corporation, Korea, in a multicentre, open label, parallel, randomized Phase II/III study design.
The study, conducted across 8 study sites in India and including 456 randomized subjects, was designed to lead to licensure in India.
The vaccine is manufactured in India by Biological E and is based on Intercell’s technology, which was successfully used to gain product licensure of the adult vaccine in Europe, the United States, Canada, Hong Kong (IXIARO®) and Australia (JESPECT®).
“We are very pleased to have reached this important milestone in our collaboration with Biological E. which moves us one step closer towards being able to provide a vaccine to protect children living in endemic areas threatened by this terrible disease. The successful completion of this Phase II/III study is a major step towards making our modern cell culture derived product available in Asia, and supports our global territory expansion” , states Thomas Lingelbach, Chief Executive Officer of Intercell AG.
Dr. Vijay Kumar Datla, Chairman and Managing Director of Biological E. Limited added: “We are excited about the successful completion of our Phase II/III clinical study which should enable us to offer this novel and safe vaccine to combat Japanese Encephalitis not only in India but also across Asia. There is an urgent need to respond to the JE epidemic throughout India and Asia where large‐scale immunization is of high importance. Through our strategic partnership with Intercell, licensure of this modern JE vaccine will allow us to ensure the vaccine reaches those who need it most.”
In March 2011, an independent data and safety monitoring board evaluated data from 160 subjects having completed their day 7 visit and concluded that the safety assessment was favorable, thus allowing the study to proceed into Phase III.
In 2005, Intercell and Biological E. signed a contract for the development, manufacturing, marketing and distribution in India and the Indian subcontinent of Intercell’s Japanese Encephalitis vaccine.
The vaccine’s further regulatory approval route for other Asian territories is expected through the World Health Organization - Novartis will be responsible for the marketing and distribution in these regions.
Following the approval and launch of Intercell’s vaccine against Japanese Encephalitis for adult travelers and military personnel in Europe, the USA and Australia, the development of a vaccine to protect children in endemic areas from Japanese Encephalitis has been a major goal of the Company.