The primary objective was to assess the efficacy of PCV13 in the prevention of a first episode of confirmed VT-CAP, defined as the presence of ≥2 prespecified clinical criteria, findings on chest radiography consistent with CAP and a positive vaccine-type–specific urinary antigen test or isolation of vaccine-type S. pneumoniae from blood or another sterile site. The secondary objectives were to assess the efficacy of PCV13 in the prevention of a first episode of confirmed VT-NB/NI CAP, that is., an episode of VT-CAP for which the result of a blood culture and results of cultures of any other sterile site were negative for S. pneumoniae and VT IPD, that is, an episode in which the presence of S. pneumoniae is detected in a sterile site. The different terminologies used in the study have been defined. The safety objective was an evaluation of the safety profile of PCV13 as measured by the incidence rates of serious adverse events for 28 days after vaccination among all participants and for 6 months after vaccination among participants in the safety subgroup.¹

Definition of Terminologies¹

CAP, community-acquired pneumonia; CAPiTA, Community-Acquired Pneumonia Immunization Trial in Adult; IPD, invasive pneumococcal disease; NB/NI, non-bacteraemic/non-invasive; PCV13, 13-valent pneumococcal conjugate vaccine; PPSV23, 23-valent pneumococcal polysaccharide vaccine; SSUAD, serotype-specific urinary antigen detection assay; VT, vaccine type.

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