Last Updated: 02/12/2024

A prospective study to evaluate the safety, effectiveness and impact of the RTS,S/AS01E vaccine in young children in sub-Saharan Africa (EPI-MAL-003)

Objectives

To estimate the incidence of adverse events of specific interests (AESI’s), and of other adverse events (AE’s) 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.

Principal Institution

Kintampo Health Research Centre (KHRC), Ghana

Principal Investigators / Focal Persons

Rationale and Abstract

This study referred to as Epi Mal 003 is a phase IV study of the RTS,S/AS01E vaccine which is the first vaccine to be implemented for the prevention of malaria. The pilot implementation of the RTS,S/AS01E vaccine follows recommendations by the World Health Organization. The vaccine is currently being implemented among pediatric populations (5-17 months) in sub-Saharan African countries within the routine health systems in Ghana, Kenya and Malawi on a pilot basis. A baseline study referred to as Epi Mal 002 began ahead of this study to measure the occurrence of adverse events of special interest (AESI), other adverse events (AE) leading to hospitalization or death, meningitis and malaria illness and death. This Epi Mal 003 study is, therefore, intended primarily as a post-implementation safety study.

Study Design