This deliverable collates into a single document the SPEAC Vaccine-associated enhanced disease tools (data abstraction & interpretation form, tabular summary of key case definition criteria and algorithm for level of certainty determination, pictorial level of certainty algorithm) and guidance (real time investigation, data collection, analysis and presentation). This guide can be used by stakeholders to assess the occurrence of Vaccine-associated enhanced disease in clinical trials or epidemiologic studies. Unlike all other Brighton case definitions, this one cannot be applied to individual case reports in a pharmacovigilance setting. It is designed for use in controlled clinical trials or settings where the frequency of cases can be compared to that seen in naturally infected, unvaccinated individuals.

The SPEAC Project is funded in whole by CEPI.