Merck (NYSE:MRK) announces positive results from two Phase 3 clinical trials assessing V114, its 15-valent pneumococcal conjugate vaccine.
Results from PNEU-AGE (V114-019) in healthy adults at least 50 years old showed that V114 was non-inferior to the currently available 13-valent pneumococcal conjugate vaccine [Pfizer’s (NYSE:PFE) Prevnar 13] for the 13 serotypes targeted by both vaccines and superior for serotypes 22F and 33F, the two additional serotypes targeted by V114. The study also met a key secondary endpoint demonstrating V114’s superiority for serotype 3, a leading cause of pneumonia globally.
Results from PNEU-TRUE (V114-020), also in healthy adults at least 50 years old, showed equivalent responses across all 15 serotypes across three different lots of V114, the primary objective.
In both studies, V114’s safety profile was comparable to that of Prevnar 13.
Additional data will be submitted for presentation at a future medical conference.
The company expects to file a U.S. marketing application before year-end. Applications in other markets will follow.
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