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Safety and non-inferiority of multidose and single-dose vial formulations of EuTCV Vi-CRM197 versus Typbar TCV in healthy participants in Kenya and Senegal: a multicentre, observer-blind, randomised, phase 3 study.

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Title: Safety and non-inferiority of multidose and single-dose vial formulations of EuTCV Vi-CRM197 versus Typbar TCV in healthy participants in Kenya and Senegal: a multicentre, observer-blind, randomised, phase 3 study.
Authors: Ndiaye BP; Institute for Health Research - Epidemiological Surveillance and Training, Dakar, Senegal., Koech L; Kenya Medical Research Institute-US Army Medical Research Directorate Africa-HJF Medical Research International, Kericho, Kenya., Mercer LD; PATH Center for Vaccine Innovation and Access, Seattle, WA, USA., Aponte JJ; PATH Center for Vaccine Innovation and Access, Geneva, Switzerland., Cisse B; Institute for Health Research - Epidemiological Surveillance and Training, Dakar, Senegal., Riziki F; Kenya Medical Research Institute-US Army Medical Research Directorate Africa-HJF Medical Research International, Kericho, Kenya., Keter W; Kenya Medical Research Institute-US Army Medical Research Directorate Africa-HJF Medical Research International, Kericho, Kenya., Eaton N; PATH Center for Vaccine Innovation and Access, Seattle, WA, USA., Diye S; Institute for Health Research - Epidemiological Surveillance and Training, Dakar, Senegal., Wade D; Institute for Health Research - Epidemiological Surveillance and Training, Dakar, Senegal., Bob NS; Institut Pasteur de Dakar, Dakar, Senegal., Raine MG; PATH Center for Vaccine Innovation and Access, Seattle, WA, USA., Her H; EuBiologics, Seoul, South Korea., Kim S; EuBiologics, Seoul, South Korea., Erdem R; PATH Center for Vaccine Innovation and Access, Seattle, WA, USA., Lee C; EuBiologics, Seoul, South Korea., Cassels FJ; PATH Center for Vaccine Innovation and Access, Seattle, WA, USA., Park Y; EuBiologics, Seoul, South Korea., Dia M; Institut Pasteur de Dakar, Dakar, Senegal., Baik YO; EuBiologics, Seoul, South Korea., Fall G; Institut Pasteur de Dakar, Dakar, Senegal., Locke E; PATH Center for Vaccine Innovation and Access, Seattle, WA, USA., Njuguna PW; PATH Center for Vaccine Innovation and Access, Nairobi, Kenya. Electronic address: pnjuguna@path.org.
Source: The Lancet. Global health [Lancet Glob Health] 2025 Dec; Vol. 13 (12), pp. e2122-e2132.
Publication Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Clinical Trial, Phase III; Equivalence Trial
Journal Info: Publisher: Elsevier Ltd Country of Publication: England NLM ID: 101613665 Publication Model: Print Cited Medium: Internet ISSN: 2214-109X (Electronic) Linking ISSN: 2214109X NLM ISO Abbreviation: Lancet Glob Health Subsets: MEDLINE
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  Data: Safety and non-inferiority of multidose and single-dose vial formulations of EuTCV Vi-CRM197 versus Typbar TCV in healthy participants in Kenya and Senegal: a multicentre, observer-blind, randomised, phase 3 study.
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  Data: <searchLink fieldCode="AU" term="%22Ndiaye+BP%22">Ndiaye BP</searchLink>; Institute for Health Research - Epidemiological Surveillance and Training, Dakar, Senegal.<br /><searchLink fieldCode="AU" term="%22Koech+L%22">Koech L</searchLink>; Kenya Medical Research Institute-US Army Medical Research Directorate Africa-HJF Medical Research International, Kericho, Kenya.<br /><searchLink fieldCode="AU" term="%22Mercer+LD%22">Mercer LD</searchLink>; PATH Center for Vaccine Innovation and Access, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Aponte+JJ%22">Aponte JJ</searchLink>; PATH Center for Vaccine Innovation and Access, Geneva, Switzerland.<br /><searchLink fieldCode="AU" term="%22Cisse+B%22">Cisse B</searchLink>; Institute for Health Research - Epidemiological Surveillance and Training, Dakar, Senegal.<br /><searchLink fieldCode="AU" term="%22Riziki+F%22">Riziki F</searchLink>; Kenya Medical Research Institute-US Army Medical Research Directorate Africa-HJF Medical Research International, Kericho, Kenya.<br /><searchLink fieldCode="AU" term="%22Keter+W%22">Keter W</searchLink>; Kenya Medical Research Institute-US Army Medical Research Directorate Africa-HJF Medical Research International, Kericho, Kenya.<br /><searchLink fieldCode="AU" term="%22Eaton+N%22">Eaton N</searchLink>; PATH Center for Vaccine Innovation and Access, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Diye+S%22">Diye S</searchLink>; Institute for Health Research - Epidemiological Surveillance and Training, Dakar, Senegal.<br /><searchLink fieldCode="AU" term="%22Wade+D%22">Wade D</searchLink>; Institute for Health Research - Epidemiological Surveillance and Training, Dakar, Senegal.<br /><searchLink fieldCode="AU" term="%22Bob+NS%22">Bob NS</searchLink>; Institut Pasteur de Dakar, Dakar, Senegal.<br /><searchLink fieldCode="AU" term="%22Raine+MG%22">Raine MG</searchLink>; PATH Center for Vaccine Innovation and Access, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Her+H%22">Her H</searchLink>; EuBiologics, Seoul, South Korea.<br /><searchLink fieldCode="AU" term="%22Kim+S%22">Kim S</searchLink>; EuBiologics, Seoul, South Korea.<br /><searchLink fieldCode="AU" term="%22Erdem+R%22">Erdem R</searchLink>; PATH Center for Vaccine Innovation and Access, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Lee+C%22">Lee C</searchLink>; EuBiologics, Seoul, South Korea.<br /><searchLink fieldCode="AU" term="%22Cassels+FJ%22">Cassels FJ</searchLink>; PATH Center for Vaccine Innovation and Access, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Park+Y%22">Park Y</searchLink>; EuBiologics, Seoul, South Korea.<br /><searchLink fieldCode="AU" term="%22Dia+M%22">Dia M</searchLink>; Institut Pasteur de Dakar, Dakar, Senegal.<br /><searchLink fieldCode="AU" term="%22Baik+YO%22">Baik YO</searchLink>; EuBiologics, Seoul, South Korea.<br /><searchLink fieldCode="AU" term="%22Fall+G%22">Fall G</searchLink>; Institut Pasteur de Dakar, Dakar, Senegal.<br /><searchLink fieldCode="AU" term="%22Locke+E%22">Locke E</searchLink>; PATH Center for Vaccine Innovation and Access, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Njuguna+PW%22">Njuguna PW</searchLink>; PATH Center for Vaccine Innovation and Access, Nairobi, Kenya. Electronic address: pnjuguna@path.org.
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              Text: 2025 Dec
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