In the context of Phase IV pharmaco-epidemiology studies for RTS,S/AS01E candidate malaria vaccine, GSK Vaccines conducted a pre-licensure study followed by a post-licensure safety study. During each of these studies, approximately forty thousand vaccinated children were closely monitored in several sites in sub-Saharan African countries.

AMP provided support for the development of the concept protocols and for the revision of final protocols for both safety studies.