CAPiTA

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).

Therapeutic areas

Total patients

85000

Total sites

58

Status

Finished

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. For any further information you can visit: www.vaccinatieonderzoek.nl or read the press release.

Services

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.

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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:

  • Data entry of source document data into the smo and clinical databases. Completed source documents were shipped from vaccination sites to the Julius Clinical headquarters via secured and tracked transport. Upon receipt of the source documents, these were entered into the applicable smo databases (edc system) by a large data entry team (around 50 people). Relevant source data was entered into the sponsor’s clinical database (edc system), as per protocol requirement. 
  • Reconciliation of data between clinical database and smo databases. To ensure consistency between the different databases used in the study, regular reconciliations on critical data elements were performed. Discrepancies were verified against the source documents and corrected as appropriate. 
  • Coordination of query resolution. Consistency reviews on clinical database data were performed on regular basis by data management staff and/or CRAs and queries might be generated. Julius Clinical’s data managers followed up on queries by consulting the appropriate investigators and sent query responses back to the CRAs or sponsor’s data manager. 
  • Database migration. As the CAPiTA study consisted of different sub-studies, different smo databases existed. To ensure consistency, efficiency and quality, all smo databases were migrated to a single smo database. Extensive testing and data comparison prior and post migration ensured data integrity after the migration. 
  • Consistency review of collected study endpoint data and submission to adjudication committee. X-ray data, which define the study endpoints, were collected on an ongoing basis and sent to our data management team via secured and tracked transport. Data were verified on completeness and consistency. Discrepancies were queried to the originating hospital. Once the data wer considered complete and consistent, they were uploaded to an independent adjudication committee who determined whether the combination of x-ray results and other clinical assessment results constituted a study endpoint.
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Site Management & 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.

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Publications

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

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