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Implementation of safety standards in PRD vaccine clinical development

Work Package Leader

Brighton Collaboration Foundation -  Prof Ulrich Heininger

Objectives

  • To identify challenges in the implementation of vaccine safety standards in PRD clinical trials, in Europe and in developing countries.
  • To generate immediate “user-feedback” for the improvement of BC safety standards in clinical trials.
  • To identify opportunities to facilitate the usage of BC safety standards in resource-poor settings.
  • To generate well-defined BC implementation proposals and partnerships.
  • To identify short term projects for consultancy services in collaboration with international agencies, academic centers, donors and regulators.

This project will set-up a working group on the implementation of safety standards in clinical trials of PRD vaccines allowing meta-analysis of the safety of similar vaccine approaches.

Deliverables

D3.1 Development of a template of safety section in clinical trial protocols; including data collection, analysis and reporting.
D3.2 Creation of a list of AEFI; specifically relevant for PRD vaccines, for which development of harmonised case definitions is needed.
D3.3 Scientific publications and/or position papers by the working group