Date: 2011-09-16
Type of information:
phase: 3
Announcement: results
Company: Intercell (Austria) Biological E. Ltd (India)
Product: Ixiaro®
Action mechanism: vaccine against Japanese Encephalitis
Disease: Japanese Encephalitis
Therapeutic area: Infectious diseases
Country: India
Trial
details: 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, randomised 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®).
Latest
news: Intercell AG and its partner Biological E. Ltd. have announced the successful completion of a pediatric Phase II/III study for the vaccine to protect children from Japanese Encephalitis (JE). Analysis of the pivotal Phase III safety and immunogenicity data showed positive results and that the study met its
primary endpoint.
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.
