Therapy Areas: Vaccines
Independent Data Monitoring Committee Recommends Discontinuation of the Phase 2b STRIVE Clinical Trial of Staphylococcus aureus Vaccine Following Planned Interim Analysis
27 December 2018 - - US-based biopharmaceutical company Pfizer Inc.'s (NYSE: PFE) 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, the company said.

This decision is based on a recommendation from an independent Data Monitoring Committee, 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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