Enrollment in Ph III JE vacc trials complete
Cambridge, UK-headquartered vaccine specialist Acambis says that it has completed patient enrollment into two pivotal Phase III clinical studies of its developmental Japanese encephalitis vaccine, ChimeriVax-JE. More than 2,800 healthy adults have been included in the two assessments which were initiated at centers in Australia and the USA late last year (Marketletter September 5, 2005).
The trials are designed to establish the product's safety and efficacy, in addition to characterizing the antibody response that a single dose of the vaccine elicits in comparison with French firm Sanofi-Pasteur's currently-licensed three-dose JE-Vax vaccine.
Acambis added that, with enrollment complete, it remains on course to file planned regulatory submissions with authorities in India and Australia during 2007.
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