Prevnar 13 Prevents Community-Acquired Pneumonia in Older Adults
Pivotal trial meets primary objective in subjects aged 65 years and older (February 24)
The Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) — a landmark study of approximately 85,000 subjects evaluating the efficacy of Prevnar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed], Pfizer) in adults 65 years of age and older — has achieved its primary clinical objective and both secondary clinical objectives.
The study’s primary objective was to demonstrate the efficacy of Prevnar 13 against a first episode of vaccine-type community-acquired pneumonia (CAP). The CAPiTA study also met both secondary objectives, which were efficacy against a first episode of non-bacteremic/non-invasive vaccine-type CAP (VT-CAP), and against a first episode of vaccine-type invasive pneumococcal disease (IPD).
VT-CAP was defined as CAP caused by any Streptococcus 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 at 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.
The results will be presented March 12 at the 9th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD)in Hyderabad, India.
In the U.S., Prevnar 13 is approved for use in children 6 weeks through 5 years of age for active immunization for the prevention of invasive disease and otitis media caused by S. pneumoniae serotypes; in children 6 through 17 years of age for active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes; and for adults 50 years of age and older for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes.
Source: Pfizer; February 24, 2014.