PF-06482077 is Pfizer's 20-Valent pneumococcal conjugate vaccine (20vPnC) candidate for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults aged 18 years and older.
“While the full extent of Prevenar 13 protection of adults is still being realized, we anticipate our 20vPnC vaccine candidate will be the next important step to help protect adults from a substantial invasive pneumococcal disease and pneumonia burden, including disease caused by serotypes not yet covered by any available conjugate vaccine,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer.
“As the industry leader in pneumococcal conjugate vaccination, we are proud to start the Phase 3 trials of our third generation pneumococcal vaccine, which received Breakthrough Therapy Designation by the FDA in September 2018.”
This first Phase 3 trial will enroll an estimated 3,880 adults and is designed to compare immune responses after 20vPnC administration to responses in control subjects ≥60 years old receiving 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine; evaluate the immunogenicity of 20vPnC in adults 18-59 years of age; and describe the 20vPnC safety profile in adults ≥18 years old.
Clinical Trial NCT03760146: Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults
Clinical Trial NCT03828617: Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
Clinical Trial NCT03835975: Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination