Evaluating Safety and Effectiveness of the RTS,SAS01 Malaria Vaccine in Children Under 5 Using Case-Control Studies in Ghana, Kenya, and Malawi

What this Trial Is About

Researchers are evaluating the RTS,SAS01 malaria vaccine through case-control studies embedded within the Malaria Vaccine Pilot Evaluation MVPE conducted in Ghana, Malawi, and Kenya. This observational study aims to assess the vaccines safety with focus on cerebral malaria, meningitis, and severe malaria, as well as its impact on all-cause mortality among children aged 6 months to 59 months. The study also supports the use of case-control methods in immunization and malaria control programs. The study involves two main case-control components clinical outcomes and mortality outcomes. For clinical outcomes, children living in MVPE areas who meet case or control definitions based on hospital surveillance are recruited, with each case matched to four controls. The mortality component recruits children who died from any cause excluding accidents or trauma and matches them with four live controls. Data collection includes administering questionnaires to caregivers at their homes and gathering information from hospital and community surveillance systems. Participants will be involved through consented data collection via questionnaires and surveillance records. Data on meningitis, severe malaria, cerebral malaria, and mortality by gender are collected and analyzed. Controls are recruited by canvassing households near cases to match age and location. The study spans 45 months, with ongoing monitoring of outcomes including hospital admissions and deaths. Findings will support vaccine safety and effectiveness assessments and inform policy decisions.

Strengthening the Evidence for Policy on the RTS,S/AS01 Malaria Vaccine