KENILWORTH (NJ) (dpa-AFX) - Merck & Co. Inc. (MRK) said it is beginning two Phase 3 studies of PCV-15 (V114), its investigational polyvalent conjugate vaccine for the prevention of pneumococcal disease.
The company noted that 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 or HIV.
Merck noted that the decision to move PCV-15 to Phase 3 is based on the findings of the Phase 1 and Phase 2 studies. The results of these studies will be presented at the upcoming International Society on Pneumococci and Pneumococcal Diseases or ISPPD, which begins on Sunday, April 15.
Eliav Barr, senior vice president of Merck Research Laboratories, said, '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.'
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