Pneumococcal disease, including pneumonia, is a major global public health problem, and older people are at greater risk, particularly for severe disease and complications. Conjugate vaccines have shown efficacy against invasive pneumococcal disease (IPD) and otitis media in children, but have not been evaluated healthy elderly. The CAPiTA study was designed was to demonstrate the efficacy of 13-valent pneumococcal conjugate vaccine (13vPnC) in prevention of a first episode of vaccine-type pneumococcal community-acquired pneumonia (CAP) (primary objective). The secondary objectives were to demonstrate efficacy in prevention of a first episode of nonbacteremic/noninvasive vaccine-type pneumococcal CAP and of vaccine-type invasive IPD. This was a randomized, double-blind clinical trial in 84,496 participants 65 and older in the Netherlands. Key eligibility criteria were no previous pneumococcal vaccination and immune competence. Participants were randomized 1:1 to receive 13vPnC or placebo. They were enrolled at community-based sites and home visits, and surveillance for CAP and IPD was conducted at hospitals in the areas of enrollment. A serotype-specific urinary antigen detection assay was used to identify episodes of vaccine-type CAP. Safety was also evaluated. The study started in September 2008, and reached the protocol defined 130 case accrual numbers of first episode of Vaccine Type CAP at the end of August 2013. The primary and secondary endpoints of this study will be presented. At the time abstract submission, the data were not yet available.(Funded by Pfizer, Inc.; ClinicalTrials.govnumber NCT00744263.)
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