Statistical Analysis Plan
presentationposted on 29.07.2019 by Michele Tameris, Helen Mearns, Adam Penn-Nicholson, Yolande Gregg, Nicole Bilek, Simbarashe Mabwe, Hennie Geldenhuys, Justine Shenje, Angelique Luabeya, Ingrid Murillo, Juana Doce, Nacho Aguilo, Dessislava Marinova, Esteban Rodriguez, Eugenia Pentes, Jesús Gonzalo-Asensio, Bernard Fritzell, Jelle Thole, Carlos Martin, Thomas Scriba, Mark Hatherill, MTBVAC Clinical Trial Team
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Statistical analysis plan for the MTBVAC 201 clinical trial. A phase Ib, randomised, double-blind, dose-escalation clinical trial of the safety, reactogenicity and immunogenicity of MTBVAC compared to BCG Vaccine SSI, in newborns living in a tuberculosis endemic region with a safety arm in adults.