A prospective study to evaluate the safety, effectiveness and impact of the RTS,S/AS01 E vaccine in young children in sub-Saharan Africa.

July 9, | Ongoing Project | Reading time: 6 min

Start Date:21-03-2019
End Date: 31-12-2024
Funders:GlaxosmithKline Biologicals SA

EPI-MAL-003 is intended primarily as a post-implementation safety study. Additionally, vaccine effectiveness and impact estimations are included as secondary objectives.

To estimate the incidence of adverse events of special interest (AESI), and of other adverse events (AE) leading to hospitalisation or death, in children vaccinated with RTS,S/AS01E. To estimate the incidence of aetiology confirmed meningitis in children vaccinated with RTS,S/AS01E.