Nabi revises StaphVax study
This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryNabi will increase the number of end-stage renal disease patients in a confirmatory Phase III trial of its Staphylococcus aureus vaccine, StaphVax, from 3,000 to 3,600. "The decision to expand the sample size was made following additional dialogue with FDA as to what would constitute a meaningful effect in the context of the adverse event profile," the company says. The larger patient population will power the study to show statistical significance with a clinical reduction of 50% or more in S. aureus infections through eight months post-vaccination; the initial Phase III study showed significant results through 10 months at a 60% reduction rate. The company estimates approximately 12 mil. U.S. patients are at risk of contracting an S. aureus infection. Nabi plans to submit an NDA by the end of 2005...
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