Guidance for vaccine safety data collection, presentation and analysis

This document summarizes Brighton Collaboration guidance on the collection, interpretation analysis and presentation of safety data relevant for CEPI candidate vaccine trials. Summary checklists are provided so CEPI developers can check the degree to which their protocols and case report forms are harmonized with published Brighton collaboration safety data guidelines for vaccine pre- and post-licensure clinical trials including those for pregnant women. It also includes sample AEFI CRFs, guidance on solicited local and systemic reactogenicity and Tier 1 AESI.

The SPEAC Project is funded in whole by CEPI.

Keywords

Guidance for developers, CEPI, Brighton Collaboration

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