The Community-Acquired Pneumonia Immunization Trial in Adults, the landmark study of approximately 85,000 subjects evaluating the efficacy of Prevenar 13 -- pneumococcal polysaccharide conjugate vaccine -- in adults age 65 and older, achieved both its primary and secondary clinical objectives, Pfizer said.
CAPiTA is the largest double-blind, randomized, placebo-controlled vaccine efficacy trial ever conducted in adults, Pfizer officials said.
"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," Dr. Emilio A. Emini, senior vice president, Vaccine Research and Development at Pfizer, said in a statement.
"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."
Prevnar 13 was licensed by the U.S. Food and Drug Administration 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.
The findings are scheduled to be presented March 12 at the 9th International Symposium on Pneumococci and Pneumococcal Diseases in Hyderabad, India.