Phase III studies initiated for PVC 15 vaccine for prevention of pneumococcal disease.- Merck inc.

Merck announced that the company is beginning two Phase III 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 III 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).

Comment: The decision to move PCV 15 to Phase III is based on the findings of Phase 1 and Phase II studies, the results of which are being presented at the upcoming International Society on Pneumococci and Pneumococcal Diseases (ISPPD), which was held on Sunday, 15 April 2018.