Two phase III trials of V 114 show efficacy of vaccine in pneumococcal disease.- Merck Inc

Merck Inc announced findings from two additional Phase III studies evaluating the safety, tolerability and immunogenicity of V 114 (PVC 15), the company’s investigational 15-valent pneumococcal conjugate vaccine for the prevention of pneumococcal disease. In the PNEU-PATH (V114-016) study, healthy adults 50 years of age or older received V114 or PCV13 followed by Pneumovax 23 one year later. Immune responses following vaccination with Pneumovax 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V 114. Results also showed that at 30 days post vaccination with either V 114 or PCV13 (day 30), immune responses were comparable for both groups across the 13 serotypes shared by the conjugate vaccines and higher in the V 114 group for serotypes 22F and 33F, the two serotypes not included in PCV13. In PNEU-DAY (V114-017), a Phase III study in immunocompetent adults 18 to 49 years of age with underlying medical conditions associated with increased risk for pneumococcal disease, V 114 generated immune responses generally comparable to PCV13 for the 13 shared serotypes and higher immune responses for serotypes 22F and 33F at 30 days post-vaccination. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. V 114 was generally well tolerated in both studies, with a safety profile consistent with that observed for V 114 in previously reported studies. Findings from the V 114 Phase III clinical program in adults, including PNEU-PATH and PNEU-DAY, will be presented at a future scientific congress. Plans for global regulatory licensure applications, beginning with the U.S. Food and Drug Administration before the end of the year, remain on track.