Replication Data for: Feasibility, safety, and impact of the RTS,S/AS01E malaria vaccine when implemented through national immunisation programmes: evaluation of cluster-randomised introduction of the vaccine in Ghana, Kenya, and Malawi

This is a replication dataset for the research publication titled: " Feasibility, safety, and impact of the RTS,S/AS01E malaria vaccine when implemented through national immunisation programmes: evaluation of cluster-randomised introduction of the vaccine in Ghana, Kenya, and Malawi ." The RTS,S/AS01E malaria vaccine (RTS,S) was introduced by national immunisation programmes in Ghana, Kenya, and Malawi in 2019 in large-scale pilot schemes. The study aimed to address questions about feasibility and impact, and to assess safety signals that had been observed in the phase 3 trial that included an excess of meningitis and cerebral malaria cases in RTS,S recipients, and the possibility of an excess of deaths among girls who received RTS,S than in controls, to inform decisions about wider use. This data comes from a study that tested a new malaria vaccine (RTS,S) in 3 African countries: Ghana, Kenya, and Malawi. The prospective evaluation involved 158 geographical clusters randomly assigned for early or delayed RTS,S vaccine doses, given between 5 months to around 2 years of age. Primary outcomes included mortality, hospital admissions for severe malaria, meningitis, cerebral malaria, gender-specific mortality, and vaccination coverage. Surveillance took place in multiple hospitals, with vaccine uptake assessed via surveys. Further study details on the methodology and results can be found in the related publication.