Vaccine Safety Assessment
During clinical trials, safety cannot be assessed directly but only inferred from the relative absence of AEFIs (Adverse Events Following Immunisation). Comparison and meta-analysis of safety results for a same type of vaccine formulation and/or different vaccines using same technologies or adjuvants require standardised case definitions and guidelines for AEFI
INYVAX will increase the awareness of Brighton safety standards among the project participants and stakeholders in international vaccine development and improve the applicability and “user-friendliness” of Brighton case definitions, data collection guidelines, and online tools.
A template of safety section in clinical trial protocols including data collection, analysis and reporting is being developed. Further, a list of AEFI specifically relevant for PRD vaccines, for which development of harmonised case definitions is needed, will be developed.
For further information on standardisation of safety assessment in clinical trials please visit: http://www.brightoncollaboration.org