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Merck Inc., announces positive topline results from two phase III adult studies evaluating V114, an investigational 15-valent pneumococcal conjugate vaccine, including pivotal trial.
Merck inc., announced that two Phase III studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, met their primary immunogenicity objectives.
The pivotal PNEU-AGE (V114-019) study in healthy adults 50 years of age or older demonstrated that V114 is non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 serotypes targeted by both vaccines and superior for serotypes 22F and 33F, the two serotypes targeted by V114 but not PCV13. These results are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. The PNEU-AGE study also met the key secondary immunogenicity objective, demonstrating superiority of V114 compared to PCV13 for serotype 3, a leading cause of invasive pneumococcal disease globally.
In another Phase III study,PNEU-TRUE (V114-020) , in healthy adults 50 years of age or older, V114 met its primary immunogenicity objective demonstrating equivalent immune response across all 15 serotypes for three different lots of V114. In both studies, V114 was generally well tolerated, with a safety profile comparable to PCV13 and consistent with that observed for V114 in previously reported studies.
These findings, and additional Phase III data from Merck’s clinical program, will be presented at a scientific congress in the future and will form the basis of global regulatory licensure applications, beginning with the U.S. Food and Drug Administration, before the end of the year.
Condition: Pneumococcal Disease
Type: drug