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Merck Says Initial Phase 3 Studies of its V114 Met Initial Safety and Immunogenicity Objectives

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from two initial Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s

Benzinga · -

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from two initial Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. 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. 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.

“Certain populations are at greater risk for pneumococcal disease, reinforcing the importance of investigating new interventions focused on their specific needs,” said Dr. Luwy Musey, executive director in biologics, vaccine clinical research, Merck Research Laboratories. “Results from these first two Phase 3 studies of V114 are encouraging and we look forward to sharing additional data in the future from our ongoing clinical development program, including our pivotal studies assessing the immunogenicity of V114 and its potential to protect against the serotypes most likely to cause invasive disease.”

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 including both healthy older adult and healthy pediatric populations, as well as people who are immunocompromised or have certain chronic conditions. An overview of the late-stage development program is available here. The company plans to continue to work with the U.S. Food and Drug Administration (FDA) and other regulatory authorities around the world on filing plans for licensure of this vaccine as additional data from the Phase 3 program become available.