Merck Announces First Phase Three Studies for PCV-15 (V114) Its Investigational Pneumococcal Disease Vaccine

Merck MRK, known as MSD outside of the United States and Canada, today announced that the company is beginning two Phase 3 studies of PCV-15 (V114), its investigational polyvalent conjugate vaccine for the prevention of pneumococcal disease. The first study (ClinicalTrials.gov, NCT03480763) will evaluate the safety, tolerability and immunogenicity of PCV-15 followed by Pneumococcal Vaccine Polyvalent one year later in healthy adult subjects 50 years of age or older. The second Phase 3 study (ClinicalTrials.gov, NCT03480802) will evaluate the safety, tolerability and immunogenicity of PCV-15 followed by Pneumococcal Vaccine Polyvalent administered eight weeks later in adults infected with human immunodeficiency virus (HIV).

The decision to move PCV-15 to Phase 3 is based on the findings of Phase 1 and Phase 2 studies, the results of which are being presented at the upcoming International Society on Pneumococci and Pneumococcal Diseases (ISPPD), which begins on Sunday, April 15.

"Merck has been a pioneer in pneumococcal and infectious disease prevention. We are building on this heritage with the development program for PCV-15," said Eliav Barr, M.D. senior vice president, Merck Research Laboratories. "Based on our Phase 1 and 2 studies of PCV-15 findings, we are initiating a comprehensive Phase 3 program to further evaluate this investigational vaccine."

About Merck

For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer's disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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