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news.Intercell and Novartis have decided to advance Intercell's experimental Pseudomonas aeruginosa vaccine into a planned double blind study in ventilated intensive care unit (ICU) patients.
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The study is expected to show a clinically meaningful and significant reduction in overall mortality between the vaccine and control group and envisages enrolling about 800 subjects.
The study is subject to final regulatory concurrence and its start is planned for first half of 2012.
Intercell and Novartis anticipate organizing the trial in various countries predominantly in the EU, involving up to 50 study sites.
Two study groups, both receiving standard of care in addition to vaccine or placebo, will be compared.
Intercell CEO Gerd Zettlmeissl said TheirPhase II data showed a statistically significant improved survival of patients vaccinated and together with Novartis move the program forward.