Statistical Analysis Plan

Tameris, Michele; Mearns, Helen; Penn-Nicholson, Adam; Gregg, Yolande; Bilek, Nicole; Mabwe, Simbarashe; Geldenhuys, Hennie; Shenje, Justine; Luabeya, Angelique; Murillo, Ingrid; Doce, Juana; Aguilo, Nacho; Marinova, Dessislava; Rodriguez, Esteban; Pentes, Eugenia; Gonzalo-Asensio, Jesús; Fritzell, Bernard; Thole, Jelle; Martin, Carlos; Scriba, Thomas; Hatherill, Mark; Team, MTBVAC Clinical Trial

doi:10.25375/uct.7970177.v1

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 Team

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.