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Independent Data Monitoring Committee Recommends Discontinuation of the Phase 2b STRIVE Clinical Trial of Staphylococcus aureus Vaccine Following Plan
2018.12.24

This article is cited from Pfizer's website:

https://www.pfizer.com/news/press-release/press-release-detail/independent_data_monitoring_committee_recommends_discontinuation_of_the_phase_2b_strive_clinical_trial_of_staphylococcus_aureus_vaccine_following_planned_interim_analysis

Independent Data Monitoring Committee Recommends Discontinuation of the Phase 2b STRIVE Clinical Trial of Staphylococcus aureus Vaccine Following Planned Interim Analysis.


Thursday, December 20, 2018 - 4:30pm
EST

NEW YORK--(BUSINESS WIRE)--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.