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Assessing safety in the RTS,S/AS01 malaria vaccine implementation programme: an overview and comparison of methods
David Schellenberg1, Mary Hamel2, Patricia Njuguna3
1London School of Hygiene and Tropical Medicine, London, UK. david.schellenberg@lshtm.ac.uk.
Abstract:
The RTS,S/AS01 malaria vaccine implementation programme evaluated safety signals from the phase 3 trial using sentinel hospital and community-based mortality surveillance. Strengthened pharmacovigilance was used to identify rare, unanticipated signals related to vaccination. Cohort event monitoring was designed to identify rare conditions of special interest. We summarise the strengths and weaknesses of these complementary approaches to safety monitoring.

