(RTTNews) - Merck & Co. Inc. (MRK) announced Tuesday positive top line results from two additional Phase 3 adult studies evaluating V114, the company's investigational 15-valent pneumococcal conjugate vaccine. The studies evaluated the safety, tolerability and immunogenicity of the vaccine.
The company noted that in PNEU-PATH (V114-016) and PNEU-DAY (V114-017) studies, V114 met primary immunogenicity objectives and elicited a strong immune response for all 15 serotypes included in the vaccine, including 22F and 33F - Serotypes Unique to V114.
In the PNEU-PATH study, healthy adults 50 years of age or older received V114 or PCV13 followed by PNEUMOVAX 23 one year later.
The PNEU-DAY Phase 3 study was in immunocompetent adults 18 to 49 years of age with underlying medical conditions associated with increased risk for pneumococcal disease.
V114 was generally well tolerated in both studies, with a safety profile consistent with that observed for V114 in previously reported studies.
Findings from the V114 Phase 3 clinical program in adults, including PNEU-PATH and PNEU-DAY, will be presented at a future scientific congress.
The V114 Phase 3 clinical development program is comprised of 16 trials investigating the safety, tolerability and immunogenicity of V114 in a variety of populations who are at increased risk for pneumococcal disease.
The company said it is on track with plans for global regulatory licensure applications, beginning with the U.S. Food and Drug Administration before the end of the year.
Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, "These data provide important information about the potential for V114 followed by PNEUMOVAX 23, a polysaccharide vaccine included in more than 90 percent of age-based adult pneumococcal immunization programs globally, to help protect healthy adults and adults who are at increased risk for pneumococcal disease."
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