ENROLLMENT COMPLETED IN STUDY OF INTERCELL'S JAPANESE ENCEPHALITIS VACCINE
Intercell has announced that the recruitment for the pivotal immunogenicity Phase III trial of its Japanese encephalitis vaccine has successfully been completed earlier than initially planned.
The pivotal Phase III trial, which is conducted at study sites in Austria, Germany and in the U.S., has now reached its randomization goal of 868 subjects. The study is designed to demonstrate non-inferiority in terms of immunogenicity of the vaccine compared to JE-VAX, in a multicenter, multinational, observer blinded, randomized parallel group design. The comparable vaccine product JE-VAX is the only Japanese encephalitis vaccine approved in the U.S.
In addition to the immunogenicity trial, the company's study program consists of several other trials, including a pivotal safety trial, a single shot trial and a co-vaccination trial for travelers. In total, more than 4000 out of approximately 5000 subjects have been randomized into the Phase III trials.