Phase III studies of V 114 meet objectives in pneumococcal disease.- Merck Inc

Merck Inc announced results from two initial Phase III studies evaluating the safety, tolerability and immunogenicity of V 114, the company’s investigational 15-valent pneumococcal conjugate vaccine for pneumococcal disease. Results from the PNEU-WAY (V114-018) study in adults 18 years of age or older living with Human Immunodeficiency Virus (HIV) showed that V114 elicited an immune response to all 15 serotypes included in the vaccine, including serotypes 22F and 33F. Results from the PNEU-FLU (V114-021) study in healthy adults 50 years of age or older showed that V114 can be given concomitantly with the quadrivalent influenza vaccine. V114 met its primary immunogenicity objective as measured by serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) and Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for all 15 serotypes contained in the vaccine at 30 days post-vaccination. In an exploratory comparative analysis, the OPA GMTs and IgG GMCs for the 13 shared serotypes between V114 and PCV13 were generally comparable between the two groups. Additionally, immune responses were higher in the V114 group compared with the PCV13 group for the two serotypes unique to V114 (22F and 33F). The safety profile of V114 was generally comparable with PCV13. These data, in addition to results from V110-029, a study evaluating PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent) in healthy adults 50 years of age or older, were published via the International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) online digital library. The company plans to continue to work with the FDA and other regulatory authorities around the world on filing plans for licensure of this vaccine as additional data from the Phase III program become available. Comment: V114 is Merck's answer to Pfizer's market-leading pneumococcal conjugate vaccine, Prevnar 13, which earned nearly $5.9 billion in sales last year.