All research studies
follow upPhase IV vaccine safety and effectiveness study

RTS,S/AS01E malaria vaccine safety and effectiveness evaluation

A multicountry Phase IV programme evaluating the safety and real-world effectiveness of the RTS,S/AS01E malaria vaccine following introduction in Ghana, Kenya and Malawi.

Reported progress85%

Safety and interim effectiveness findings published; follow-up and evidence translation continue.

Study overview

The EPI-MAL-003 programme was embedded within routine health-care delivery and the Malaria Vaccine Implementation Programme. It combined prospective cohort event monitoring and hospital-based surveillance to evaluate vaccine safety, impact and effectiveness outside a conventional efficacy trial. CREATES-linked investigator participation contributes Kenyan clinical-research and implementation experience to a collaboration spanning Ghana, Kenya and Malawi.

Results and current findings

Published analyses report the vaccine safety profile through one year after the primary three-dose schedule and interim evidence on effectiveness in routine practice. The programme provides evidence needed for vaccine policy, delivery and post-introduction monitoring.