The approved indications for Prevenar 13 (pneumococcal polysaccharide conjugate vaccine) in adults have been expanded to include the prevention of pneumonia caused by Streptococcus pneumoniae, in addition to the prevention of invasive pneumococcal disease.
Data to support licensing for the new indication were provided by the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), a double-blind, single-center trial in 84,496 adults aged 65 years or older who were randomly assigned to receive a single dose of either Prevenar 13 or placebo.
Participants vaccinated with Prevenar 13 experienced 45.6% fewer first episodes of vaccine-type community-acquired pneumonia (CAP; primary endpoint) than those who received placebo (p=0.0006).
In terms of secondary endpoints, there were 45.0% fewer first episodes of non-bacteraemic/non-invasive vaccine-type CAP (p=0.0067) and 75.0% fewer first episodes of vaccine-type invasive pneumococcal disease (p=0.0005) in the Prevenar 13 group than the placebo group.
Additional data showed reductions in vaccine-type CAP, non-bacteraemic/non-invasive vaccine-type CAP, and vaccine-type invasive pneumococcal disease for up to 4 years after Prevenar 13 vaccination.
The safety profile of Prevenar 13 was consistent with that observed in previous studies in adults.
Results of CAPiTA were presented during the late-breaker session at the 9th International Symposium on Pneumococci and Pneumococcal Diseases in Hyderabad, India, on March 12, 2014.