20180312 MTBVAC 201 SAP v1.0_JvT JF IM.pdf (992.35 kB)
Statistical Analysis Plan
presentation
posted on 2019-07-29, 12:31 authored 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 ScribaThomas Scriba, Mark Hatherill, MTBVAC Clinical Trial TeamStatistical 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.