Pfizer's Bacterial Infection Vaccine Failed to Meet its Primary Endpoint in P-III (CLOVER) Study
- The P-III (CLOVER) study evaluates the efficacy, safety, and tolerability of a PF-06425090 vs PBO in adults aged ≥ 50yrs. for the prevention of CDI. Participants in the trial were randomized to receive three doses of the vaccine at 0, 1 and 6mos.
- The study did not meet its pre-specified 1EPs for the prevention of primary CDI. The vaccine only showed an efficacy of 31% in preventing the infections post-dose 3, and 28.6% post dose-2 in the study
- For all CDI cases recorded @14 days post-dose 3, vaccine efficacy was 49%, 47%, and 31% up to 12mos., 24mos. and at the final analysis, respectively. Pfizer will assess data and will determine the next steps for its C. difficile vaccine program
Ref: Business wire | Image: Pfizer
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