CAPiTA is the largest vaccine trial worldwide conducted to date in older adults. Its primary objective was to establish the efficacy of a 13-valent pneumococcal vaccine in preventing a first episode of vaccine serotype-specific pneumococcal community-acquired pneumonia (CAP).
The study was designed jointly by the manufacturer of the vaccine and academic investigators linked to Julius Clinical. It was a parallel group, randomised, placebo-controlled double-blind trial, involving 85,000 subjects aged 65 and older in the Netherlands.
Julius Clinical took the lead role in establishing and managing an extensive national network of more than 2,000 GPs in order to quickly achieve the recruitment goals. The primary clinical objective, and also both secondary clinical objectives, were achieved.
For CAPiTA, the principal investigator was Dr. Marc Bonten, who is a Professor of Molecular Epidemiology of Infectious Diseases.
PROJECT MANAGEMENT
The main characteristics for this unique study were that the logistics were very complex, it needed a strong campaigning team for recruitment and demanded a high flexibility in project management. In total, Julius Clinical managed a network of 2,200 GPs and 55 hospitals for CAPiTA. In order to reach that goal, we implemented a regional approach that best fit local circumstances and made use of a milestone-system which checked progress continuously and defined the next actions.
PHARMACOVIGILANCE
In this study, Julius Clinical was responsible for providing accurate and timely medical information, which mainly consisted of questions from investigators and local site staff. We had access to highly professional and flexible SAE physicians and SAE associates so we could operate effective and efficiently. Our team managed a large volume of case handling under high pressure circumstances.
DATA MANAGEMENT
For the CAPiTA study our Data Management team was involved in the following activities:
SITE MANAGEMENT AND MONITORING
In the case of CAPiTA, the sites to be managed did not only consist of 58 hospitals but also included our network of 2,200 GPs. The site management and monitoring was a 24/7 activity performed by our trained staff. Precise planning was essential to the success of this trial.
Rationale and design of CAPITA: a RCT of 13-valent conjugated pneumococcal vaccine efficacy among older adults
Hak E, Grobbee DE, Sanders EA, Verheij TJ, Bolkenbaas M, Huijts SM, Gruber WC, Tansey S, McDonough A, Thoma B, Patterson S, van Alphen AJ, Bonten MJ. Rationale and design of CAPITA: a RCT of 13-valent conjugated pneumococcal vaccine efficacy among older adults. Neth J Med. 2008 Oct;66(9):378-83. Review. PubMed PMID: 18990781
