Pfizer announces positive top-line results of landmark community-acquired pneumonia immunization trial in adults evaluating efficacy of prevenar 13

Pfizer Inc. (NYSE: PFE) today announced that the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), the landmark study of approximately 85,000 subjects evaluating the efficacy of Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) in adults 65 years of age and older, achieved its primary clinical objective and both secondary clinical objectives. CAPiTA is the largest double-blind, randomized, placebo-controlled vaccine efficacy trial ever conducted in adults.

The primary objective of the study was to demonstrate efficacy of Prevenar 13 against a first episode of vaccine-type community-acquired pneumonia (CAP). The CAPiTA study also met both secondary objectives, which were efficacy against (i) a first episode of non-bacteremic/non-invasive vaccine-type CAP and (ii) a first episode of vaccine-type invasive pneumococcal disease (IPD).

Vaccine-type CAP (VT-CAP) was defined as CAP caused by any S. pneumoniae serotype included in the vaccine. Non-bacteremic/non-invasive VT-CAP was defined as CAP in which vaccine-type S. pneumoniae caused the pneumonia, but was not detected concurrently in the bloodstream or any other normally sterile site. Vaccine-type IPD was defined as a case in which vaccine-type S. pneumoniae was present in the bloodstream or any other normally sterile site, with or without pneumonia.

“We are pleased with the outcome of the CAPiTA study, which demonstrated that Prevenar 13 can prevent vaccine-type pneumococcal community-acquired pneumonia in adults,” said Dr. William Gruber, senior vice president, Vaccine Clinical Research, Pfizer.

“Pneumococcal pneumonia is a significant cause of illness and death in adults around the world, and the potential to reduce the burden of this disease through direct vaccination of adults represents a meaningful public health benefit,” said Dr. Emilio A. Emini, senior vice president, Vaccine Research and Development, Pfizer. “Pfizer looks forward to sharing the CAPiTA data with U.S. and worldwide regulatory authorities, and vaccine technical committees, to help inform decisions regarding potential Prevenar 13 label and recommendation updates.”

The CAPiTA data will be an important component in any consideration of potential new or updated Prevenar 13 recommendations for adults. In addition, other key factors will be taken into consideration, such as the current burden of pneumococcal disease in adults.

Prevnar 13 was licensed by the FDA under an accelerated approval process to address an unmet medical need in older adults. As a requirement of the accelerated approval pathway, Pfizer conducted CAPiTA to verify clinical benefit.

Detailed results will be presented at the 9th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Hyderabad, India, on March 12, 2014, during the late-breaker session from 2:30 p.m. to 4:10 p.m. IST/5 a.m. to 6:40 a.m. EDT.