Phase 3 CLOVER Trial for Pfizer’s Investigational Clostridioides Difficile Vaccine Indicates Strong Potential Effect in Reducing Duration and Severity of Disease Based on Secondary Endpoints | Pfizer
Pre-specified secondary endpoint showed 0-11 vaccine to placebo case split for medically attended C. difficile infection (CDI), corresponding to 100% vaccine efficacy Median CDI duration was 1 versus 4 days and mean duration was 3 versus 16 days comparing vaccine to placebo, corresponding to a 75% and 80% reduction in disease episode, respectively, in vaccinated people Vaccine was very well tolerated and showed a favorable safety profile Trial did not meet its pre-specified primary endpoint of prevention of primary CDI, however, for all CDI cases recorded at 14 days post dose 3, vaccine efficacy was 49%, 47% and 31% up to 12 months, 24 months and at final analysis, respectively Company evaluating next steps for C. difficile vaccine program in coordination with regulatory agencies Pfizer Inc. (NYSE:PFE) today announced results from the CLOVER trial ( CLO stridium difficile V accine E fficacy T R ial), a pivotal Phase 3 study evaluating its Clostridioides difficile ( C. difficile )