Prevnar 13 Landmark Trial Meets Primary Objective
Pfizer announced that the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) evaluating the efficacy of Prevnar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) achieved its primary clinical objective and both secondary clinical objectives.
CAPiTA is a double-blind, randomized, placebo-controlled study that enrolled approximately 85,000 patients to evaluate the efficacy of Prevnar 13 in adults >65 years old. This trial was conducted by Pfizer as part of the FDA's requirements under its accelerated approval program.
The primary objective was to demonstrate efficacy against a first episode of vaccine-type community-acquired pneumonia (CAP). Secondary objectives included efficacy against a first episode of non-bacteremic/non-invasive vaccine-type CAP, and a first episode of vaccine-type invasive pneumococcal disease (IPD).
Prevnar 13 is already indicated for the immunization of adults >50 years old for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains; for the prevention of invasive disease caused by the 13 vaccine strains in children 6 weeks–17 years of age; and for the prevention of otitis media caused by 7 of the 13 strains in children 6 weeks–5 years of age.
Full results will be presented at the 9th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) on March 12, 2014.
For more information, call (800) 505-4426 or visit Prevnar13.com.