CAPITA

85.000 patients, 2000 general practitioners, finalised Jan 2010
Julius Clinical Research undertook the largest vaccine trial in adults over 65 years old. The primary objective of CAPITA (Community Acquired Pneumonia Immunization Trial in Adults) is to establish the efficacy of a 13-valent pneumococcal vaccine in the prevention of a first episode of vaccine-serotype specific pneumococcal community-acquired pneumonia (CAP).
This parallel group, randomised, placebo-controlled double-blind trial included close to 85.000 subjects aged 65 and older, from a single country. The trial has been initiated  and designed in productive interaction between academic investigators from the Julius Center and the  manufacturer of the vaccine. The occurrence of the primary outcome of vaccine-serotype specific-CAP will be established in 55 participating hospitals on the basis of 3 sets of criteria: (1) a clinical definition of CAP; (2) independent interpretation of chest radiograph consistent with pneumonia; and (3) determination of S. pneumonia serotype. In addition to the primary objectives of the trial, several substudy objectives are currently under development to maximize opportunities to learn about the health conditions in this older adult population.

CAPiTA Movie.

Publications:

Hak E, Grobbee DE, Sanders EAM, Verheij TJM, Bolkenbaas M, Huijts SM, Gruber WC,
Tansey S, McDonough A, Thoma B, Patterson S, van Alphen AJ, Bonten MJM. Rationale and design of CAPITA: a RCT of 13-valent conjugated pneumococcal vaccine efficacy among older adults. The Netherlands Journal of Medicine 2008;66:378-383.