Independent Data Monitoring Committee Recommends Discontinuation of the Phase 2b STRIVE Clinical Trial of Staphylococcus aureus Vaccine Following Planned Interim Analysis
- Category: Vaccines
- Published on Friday, 21 December 2018 14:48
- Hits: 591
NEW YORK, NY, USA I December 20, 2018 I Pfizer Inc. (NYSE:PFE) announced today that the Phase 2b trial STRIVE (STaphylococcus aureus SuRgical Inpatient Vaccine Efficacy) evaluating the company’s investigational Staphylococcus aureus (S. aureus) multi-antigen vaccine (PF-06290510) is being discontinued due to futility. This decision is based on a recommendation from an independent Data Monitoring Committee (DMC), composed of external experts, after conducting a pre-planned interim analysis.
The DMC concluded from these data that the study reached futility, meaning that there is low statistical probability for the study to meet the pre-defined primary efficacy objective in adults undergoing elective spinal fusion surgery after completing a planned Phase 3 expansion of the study.
A safety review by the DMC indicated that the investigational vaccine has been safe and well tolerated. STRIVE trial participants who are enrolled in the study will complete the study’s follow-up evaluations.
Pfizer is evaluating next steps for the potential development of a S. aureus vaccine.
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