Merck Announces First Phase Three Studies for PCV-15 (V114) Its Investigational Pneumococcal Disease Vaccine
April 17, 2018 7:30 am ET
Merck (NYSE: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
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Merck
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