05.09.11
Pfizer met all study endpoints in two Phase III immunogenicity and safety trials of Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in adults aged 50 years and older. This data was used for the regulatory filings that have been submitted in the U.S., the EU and other countries.
Data from both studies showed that Prevnar 13 was as immunogenic as the currently licensed nonconjugated pneumococcal polysaccharide vaccine (PPSV) for the 12 serotypes common to both vaccines in the age groups studied who were either pneumococcal vaccine-naïve or previously immunized with PPSV. Also, the secondary endpoint data from both studies showed that Prevnar 13 had a statistically significant higher functional antibody response than PPSV against a majority of serotypes common to both vaccines and serotype 6A, a serotype not contained in PPSV.
“Prevnar 13 represents an important scientific achievement and we are excited about the potential to further define its clinical utility with the aim of broadening pneumococcal disease prevention efforts,” says Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer Inc. “Adults 50 years and older are a population at heightened risk for pneumococcal disease, which imposes a significant public health and economic burden worldwide.”
Data from both studies showed that Prevnar 13 was as immunogenic as the currently licensed nonconjugated pneumococcal polysaccharide vaccine (PPSV) for the 12 serotypes common to both vaccines in the age groups studied who were either pneumococcal vaccine-naïve or previously immunized with PPSV. Also, the secondary endpoint data from both studies showed that Prevnar 13 had a statistically significant higher functional antibody response than PPSV against a majority of serotypes common to both vaccines and serotype 6A, a serotype not contained in PPSV.
“Prevnar 13 represents an important scientific achievement and we are excited about the potential to further define its clinical utility with the aim of broadening pneumococcal disease prevention efforts,” says Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer Inc. “Adults 50 years and older are a population at heightened risk for pneumococcal disease, which imposes a significant public health and economic burden worldwide.”