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Tuesday, October 20, 2020

Merck's 15-valent pneumonia vaccine successful in two more late-stage studies

  • Merck (NYSE:MRK) announces positive results from two Phase 3 clinical trials, PNEU-PATH and PNEU-DAY, evaluating the safety, tolerability and immunogenicity of V114, its 15-valent pneumococcal conjugate vaccine.
  • PNEU-PATH enrolled 652 healthy adults at least 50 years old who received V114 or Pfizer's (NYSE:PFE) Prevnar 13 followed by Merck's Pneumovax 23 one year later.
  • Immune responses following vaccination with Pneumovax 23 (month 13) were comparable in both arms for the 15 serotypes in V114. Immune responses were also comparable in both arms across the 13 serotypes shared by V114 and Prevnar 13 and higher in serotypes 22F and 33F, the two additional serotypes covered in V114.
  • PNEU-DAY enrolled 1,514 adults aged 18-49 who were at increased risk for pneumococcal disease due to an underlying medical condition, behavioral habits or living in an environment with increased risk of disease transmission.
  • V114 elicited immune responses generally comparable to Prevnar 13 for the 13 shared serotypes and higher immune responses for serotypes 22F and 33F 30 days post-vaccination.
  • Detailed data from the V114 Phase 3 program, including results from these two studies, will be presented at a future medical conference.
  • It plans to file a U.S. marketing application before year-end.
  • https://seekingalpha.com/news/3623574-mercks-15-valent-pneumonia-vaccine-successful-in-two-late-stage-studies

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