A phase 4 vaccine effectiveness Study on iNVASIVE pNEUMONOCOCCAL DISEASE

A biopharmaceutical company engaged us to conduct multiple post-authorization pneumococcal vaccine effectiveness studies against invasive pneumococcal disease (IPD). We assessed feasibility, set up a network of sites in Europe and beyond, wrote study protocols, and launched the first study with P95 as the sponsor.

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Study type

Observational Phase 4

Location

Czechia, Israel and Spain

Therapeutic area

Pneumococcal

Client challenge

A biopharmaceutical company had to evaluate the post-authorization vaccine effectiveness of their pneumococcal vaccine against IPD in children and adults as part of a commitment to the European Medicines Agency (EMA). This required an assessment of the feasibility of conducting multicenter effectiveness studies using the Broome (indirect cohort) method with real-world observational data, development of study protocols, and conduct of the studies.  

Our solution

By leveraging our network, we identified potential collaborators/study sites in Europe and beyond with access to IPD surveillance and serotyping data, such as national or regional pneumococcal reference laboratories and hospital networks. We conducted feasibility interviews to assess, among other things, a site’s access to IPD and vaccination data and willingness to collaborate. We invited sites with a positive outcome to join the network. The network currently consists of five sites, is growing, and will be used to conduct multiple pneumococcal vaccine effectiveness studies in different age groups. 

P95 experts in pneumococcal vaccine effectiveness research developed study protocols in collaboration with our client and which were submitted to EMA by our client. We engaged with subject matter experts in the field to gather further input on the protocol.  

The first study was launched in Q4 2024, with P95 as the sponsor being responsible for all operational aspects of the study. Throughout the study, P95 maintains a strong line of communication with site investigators in the network. P95 is responsible for all stages of the study following data upload by the sites, including data management, statistical analysis, providing regular progress reports to the client, writing the study report, and writing scientific communications (e.g., manuscripts and conference abstracts). 