Safety of RTS,S/AS01E malaria vaccine up to 1 year after the third dose in Ghana, Kenya, and Malawi (EPI-MAL-003): a phase 4 cohort event monitoring study.

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Title: Safety of RTS,S/AS01E malaria vaccine up to 1 year after the third dose in Ghana, Kenya, and Malawi (EPI-MAL-003): a phase 4 cohort event monitoring study.
Authors: Haine V; GSK, Wavre, Belgium. Electronic address: valerie.x.haine@gsk.com., Oneko M; Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya., Debois M; GSK, Wavre, Belgium., Ndeketa L; Malawi Liverpool Wellcome Research Programme, Blantyre, Malawi; Life Sciences and Allied Health Professions, Kamuzu University of Health Sciences, Blantyre, Malawi; Department of Clinical Infection, Microbiology and Immunology, University of Liverpool, UK., Agyapong PD; Kintampo Health Research Centre, Research and Development Division, Ghana Health Service, Kintampo, Ghana., Boahen O; Kintampo Health Research Centre, Research and Development Division, Ghana Health Service, Kintampo, Ghana., Harrison SBE; Kintampo Health Research Centre, Research and Development Division, Ghana Health Service, Kintampo, Ghana., Adeniji E; Kintampo Health Research Centre, Research and Development Division, Ghana Health Service, Kintampo, Ghana., Kaali S; Kintampo Health Research Centre, Research and Development Division, Ghana Health Service, Kintampo, Ghana., Kayan K; Kintampo Health Research Centre, Research and Development Division, Ghana Health Service, Kintampo, Ghana., Owusu-Agyei S; Kintampo Health Research Centre, Research and Development Division, Ghana Health Service, Kintampo, Ghana., French N; Malawi Liverpool Wellcome Research Programme, Blantyre, Malawi; Department of Clinical Infection, Microbiology and Immunology, University of Liverpool, UK., Kariuki S; Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya., Devadiga R; GSK, Bangalore, India., Ogutu B; Centre for Research in Therapeutic Sciences (CREATES), Strathmore University, Nairobi, Kenya; Kenya Medical Research Institute, Centre for Clinical Research, Nairobi, Kenya., Ansah NA; Navrongo Health Research Centre, Research and Development Division, Ghana Health Service, Navrongo, Ghana., Orsini M; 4 Clinics, Waterloo, Belgium; Aixial Group, Boulogne-Billancourt, France., Ansah PO; Navrongo Health Research Centre, Research and Development Division, Ghana Health Service, Navrongo, Ghana., Maleta K; School of Global and Public Health, Kamuzu University of Health Sciences, Blantyre, Malawi., Ong'echa JM; Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya., Phiri VK; Malawi Liverpool Wellcome Research Programme, Blantyre, Malawi., Mzanga P; Malawi Liverpool Wellcome Research Programme, Blantyre, Malawi., Jere TM; Malawi Liverpool Wellcome Research Programme, Blantyre, Malawi., Azongo DK; Navrongo Health Research Centre, Research and Development Division, Ghana Health Service, Navrongo, Ghana., Mategula D; Malawi Liverpool Wellcome Research Programme, Blantyre, Malawi; School of Global and Public Health, Kamuzu University of Health Sciences, Blantyre, Malawi; Liverpool School of Tropical Medicine, Liverpool, UK., Orimbo J; Centre for Research in Therapeutic Sciences (CREATES), Strathmore University, Nairobi, Kenya; Kenya Medical Research Institute, Centre for Clinical Research, Nairobi, Kenya., Oduro AR; Navrongo Health Research Centre, Research and Development Division, Ghana Health Service, Navrongo, Ghana., Otieno W; Kenya Medical Research Institute (KEMRI)-Walter Reed Project, US Army Medical Research Directorate-Kenya, Kombewa, Kenya., Kaburise MB; Navrongo Health Research Centre, Research and Development Division, Ghana Health Service, Navrongo, Ghana., Ababio LO; Navrongo Health Research Centre, Research and Development Division, Ghana Health Service, Navrongo, Ghana., Sifuna PM; Kenya Medical Research Institute (KEMRI)-Walter Reed Project, US Army Medical Research Directorate-Kenya, Kombewa, Kenya., Amoit SK; Kenya Medical Research Institute (KEMRI)-Walter Reed Project, US Army Medical Research Directorate-Kenya, Kombewa, Kenya., Olewe F; Centre for Research in Therapeutic Sciences (CREATES), Strathmore University, Nairobi, Kenya., Oyieko JN; Kenya Medical Research Institute (KEMRI)-Walter Reed Project, US Army Medical Research Directorate-Kenya, Kombewa, Kenya., Achieng Oguk E; Kenya Medical Research Institute (KEMRI)-Walter Reed Project, US Army Medical Research Directorate-Kenya, Kombewa, Kenya., Guerra Mendoza Y; GSK, Wavre, Belgium., Awuni D; Navrongo Health Research Centre, Research and Development Division, Ghana Health Service, Navrongo, Ghana., Sing'oei V; Kenya Medical Research Institute (KEMRI)-Walter Reed Project, US Army Medical Research Directorate-Kenya, Kombewa, Kenya., Onyango I; Kenya Medical Research Institute (KEMRI)-Walter Reed Project, US Army Medical Research Directorate-Kenya, Kombewa, Kenya., Schuerman L; GSK, Wavre, Belgium., Ochieng BO; Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya., Okoth GO; Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya., Nyangulu W; School of Global and Public Health, Kamuzu University of Health Sciences, Blantyre, Malawi., Cherop RY; Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya., Odera-Ojwang P; Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya., Cravcenco C; GSK, Wavre, Belgium., Chipatala R; School of Global and Public Health, Kamuzu University of Health Sciences, Blantyre, Malawi., Roman F; GSK, Wavre, Belgium., Savic M; GSK, Wavre, Belgium., Asante KP; Kintampo Health Research Centre, Research and Development Division, Ghana Health Service, Kintampo, Ghana; London School of Hygiene & Tropical Medicine, London, UK.
Source: The Lancet. Global health [Lancet Glob Health] 2025 Jun; Vol. 13 (6), pp. e995-e1005. Date of Electronic Publication: 2025 Apr 24.
Publication Type: Clinical Trial, Phase IV; Journal Article; Observational Study
Journal Info: Publisher: Elsevier Ltd Country of Publication: England NLM ID: 101613665 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2214-109X (Electronic) Linking ISSN: 2214109X NLM ISO Abbreviation: Lancet Glob Health Subsets: MEDLINE
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  Data: Safety of RTS,S/AS01<subscript>E</subscript> malaria vaccine up to 1 year after the third dose in Ghana, Kenya, and Malawi (EPI-MAL-003): a phase 4 cohort event monitoring study.
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