Pfizer announced topline data from one of its phase 3 studies for 20-valent pneumococcal conjugate vaccine (20vPnC) for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults aged ≥18 years.
The randomized, double-blind trial included 3880 adults aged ≥18 years who were pneumococcal vaccine-naive. The trial was designed to compare immune responses in patients aged ≥60 years after 20vPnC administration to responses in a control group receiving 13-valent pneumococcal conjugate vaccine (Prevnar 13) or 23-valent polysaccharide vaccine (PPSV23). The immune response of 20vPnC in patients aged 18 to 59 years were also assessed (secondary end point), along with the safety profile of 20vPnC in all patients aged ≥18 years (primary end point).
Results showed that the primary immunogenicity objectives of noninferiority for the 20 serotypes in 20vPnC in patients aged ≥60 years at 1 month after vaccination were met for all serotypes in common with Prevnar 13, and 6 of the 7 additional serotypes when compared with PPSV23; 1 of the new 7 serotypes missed noninferiority by a small margin. All 20 serotypes also met secondary immunogenicity objectives for patients aged 18 to 59 years when compared with those 60 to 64 years of age.
The safety of 20vPnC was comparable to licensed pneumococcal vaccines meeting study objectives. The Company will seek to present and publish outcomes from this study at a future date once safety and immunogenicity data have been fully analyzed.
“We are encouraged by the results from this study and remain on track to file the adult 20vPnC indication with the FDA by the end of 2020. 20vPnC builds on a well-established and trusted foundation of pneumococcal conjugate experience and science that Pfizer has accumulated for more than 20 years,” said Kathrin U. Jansen, PhD, SVP and Head of Vaccine Research & Development, Pfizer.
The Food and Drug Administration (FDA) previously granted Breakthrough Therapy and Fast Track designations to 20vPnC for this indication.
For more information visit pfizer.com.