Pfizer Inc. today announced that the data from its two pivotal Phase 3 immunogenicity and safety trials of Prevnar 13 in adults aged 50 years and older met all study endpoints. These studies provide the clinical foundation for the regulatory filings that have been submitted in the United States, the European Union and more than a dozen other countries. The results are being presented today at the 21st European Congress of Clinical Microbiology and Infectious Diseases and the 27th International Congress of Chemotherapy (ECCMID/ICC) in Milan, Italy.
Highlighting the results, the data from both studies showed that Prevnar 13 was at least 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-naive or previously immunized with PPSV.
Furthermore, the secondary endpoint data from both studies showed that Prevnar 13 elicited a statistically significantly higher functional antibody response than PPSV against a majority of serotypes common to both vaccines and serotype 6A, a serotype not contained in PPSV.
"Both pivotal studies met their primary objectives and demonstrated that Prevnar 13 was at least as immunogenic to PPSV for the 12 disease-causing serotypes common to both vaccines," says Lisa A.
Jackson, MD, MPH, principal investigator, Group Health Research Institute, Seattle, Washington. "The data also showed that Prevnar 13 induced significantly higher levels of functional antibodies than PPSV in the adults studied for the majority of the common serotypes." Prevnar 13, which is based on the scientific foundation of Prevnar(R) (Pneumococcal 7-valent Conjugate Vaccine Diphtheria CRM197 Protein), was first introduced in December 2009 in Europe and is now approved for use in infants and young children in more than 90 countries worldwide. Prevnar 13, like Prevnar, uses company-pioneered conjugation technology that has been shown to confer a high antibody response in infants and toddlers.
"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, PhD, 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."