Ongoing Project

EPI-MAL-003

A prospective study to evaluate the safety, effectiveness and impact of the RTS,S/AS01E vaccine in young children in sub-Saharan Africa in Peri-urban Community

July 9,2022 | Ongoing Project | Reading time: 6 min

Investigators

Dr. Kwaku Poku Asante, Dr. Seyram Kaali, Dr. Samuel Ekow Harrison, Dr. Prince Agyapong, Mr. Owusu Boahen


Background
GSK Biologicals has developed a malaria vaccine, RTS,S/AS01E, for routine immunisation of children living in malaria-endemic countries of sub-Saharan Africa (SSA). RTS,S/AS01E is the first vaccine implemented for the prevention of malaria and is being giving to the paediatric population.



Objectives


  • 1.To estimate the incidence of Adverse Events of Specific Interests (AESI) and of other Adverse Events (AE) leading to hospitalisation or death, in children vaccinated with RTS,S/AS01E.


  • 2.To estimate the incidence of aetiology-confirmed meningitis in children vaccinated with RTS,S/AS01E.



Methodology
The study uses multiple data source to increase opportunity to capture the event of interest such as home visits, hospitalization visits and outpatient visits.



Expected Outcome
To estimate the incidence of Adverse Events of Specific Interest, and of other Adverse Events leading to hospitalisation or death, and an etiology confirmed meningitis in children vaccinated with RTS, S/AS01E.



Funders
GlaxoSmithKline Biologicals