Pfizer presents detailed results from landmark Community-Acquired Pneumonia immunization Trial in Adults evaluating efficacy of prevenar 13*

Pfizer Inc. (NYSE:PFE) today presented detailed results of the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), the landmark study of approximately 85,000 subjects, demonstrating that Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) prevented a first episode of vaccine-type community-acquired pneumonia (CAP) in adults 65 years of age and older, the study’s primary objective. This trial is the first in adults to clearly demonstrate a significant reduction in vaccine-type pneumococcal CAP, and importantly, non-bacteremic/non-invasive vaccine-type pneumococcal CAP. Results were presented during the late-breaker session at the 9th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Hyderabad, India, on March 12, 2014.

CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) also met both of its secondary study objectives –significant reduction in (i) non-bacteremic/non-invasive vaccine-type pneumococcal CAP and (ii) vaccine-type invasive pneumococcal disease (IPD).

Regarding the study’s primary objective, there were 45.56 percent fewer first episodes of vaccine-type CAP among Prevenar 13-vaccinated subjects than in subjects who received placebo (P=0.0006). Regarding the study’s secondary objectives, the Prevenar 13 group experienced 45.00 percent fewer first episodes of non-bacteremic/non-invasive vaccine-type CAP (P=0.0067) and 75.00 percent fewer first episodes of vaccine-type IPD (P=0.0005) compared with the placebo group. The safety profile of Prevenar 13 in this study was consistent with studies previously conducted in adults.

Additional data showed reductions in vaccine-type CAP, non-bacteremic/non-invasive vaccine-type CAP, and vaccine-type IPD for up to four years after vaccination among subjects who received Prevenar 13.

“With the aging of the population, hospitalizations due to pneumococcal pneumonia represent a growing burden to public health systems. Evidence from this study is particularly important for a population in which age-related decline of the immune system makes it difficult to prevent disease,” said Dr. Emilio A. Emini, senior vice president, Vaccine Research and Development, Pfizer.

“This study demonstrated that vaccination with Prevenar 13 can prevent a significant portion of pneumococcal community-acquired pneumonia in adults aged 65 and older, which is an important global public health goal,” said principal investigator Prof. Marc Bonten, professor of Molecular Epidemiology of Infectious Diseases, Department of Medical Microbiology, Julius Center for Health Sciences & Primary Care, University Medical Center Utrecht in the Netherlands.

The CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) study data will be an important part of any consideration of potential new or updated recommendations for Prevenar 13 in adults. Other key factors also are expected to be taken into consideration, including the current burden of pneumococcal disease in adults.