Merck announces positive topline results from PNEU-DIRECTION (V114-027) and PNEU-PLAN (V114-024) phase III pediatric studies for V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine.

Merck Inc.,announced V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, met its primary immunogenicity and safety endpoints in two trials of the V114 Phase III pediatric clinical program. These data support the potential use of V114 in healthy infants who may have previously started a pneumococcal vaccination series with the currently available 13-valent pneumococcal conjugate vaccine (PCV13) (PNEU-DIRECTION), and in a catch-up setting for healthy children who were either pneumococcal vaccine-naïve or who previously received a full or partial regimen with lower valency pediatric pneumococcal conjugate vaccines (PCV) (PNEU-PLAN). In the PNEU-DIRECTION (V114-027) interchangeability study in healthy infants 42-90 days of age, immune responses in those who received a four-dose series of PCV13, and those who received a mixed dose schedule of PCV13 followed by V114, were generally comparable for the 13 serotypes, or strains of pneumococcal disease, targeted by both vaccines. In the PNEU-PLAN (V114-024) catch-up study, immune responses were generally comparable to PCV13 for the 13 shared serotypes when V114 was used as a catch-up regimen in healthy children 7 months to 17 years of age who were either pneumococcal vaccine-naïve or who previously received a partial or full regimen of a licensed pediatric PCV. For serotypes 22F and 33F, two serotypes included in V114 but not PCV13, immunogenicity in PNEU-PLAN was higher in the V114 group than in the PCV13 group. In each study, V114 was generally well-tolerated, with a safety profile comparable to PCV13. Full results from PNEU-DIRECTION and PNEU-PLAN will be presented at a future scientific congress. The V114 Phase III 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 healthy older adults and children, as well as people who are immunocompromised or have certain chronic medical conditions. Plans are on track for submission of a supplemental regulatory licensure application to the FDA for use in children before the end of the year, pending action on the adult Biologics Licensure Application currently under FDA review. Merck is involved in litigation challenging the validity of several Pfizer Inc. patents that relate to pneumococcal vaccine technology in the United States and several foreign jurisdictions.