Statistical Analysis Plan

Michele Tameris,Helen Mearns,Adam Penn-Nicholson,Yolande Gregg,Nicole Bilek,Simbarashe Mabwe,Hennie Geldenhuys,Justine Shenje,Angelique Kany Kany Luabeya,Ingrid Murillo,Juana Doce,Nacho Aguilo,Dessislava Marinova,Esteban M. Rodríguez,Eugenia Pentes,Jesús Gonzalo-Asensio,Bernard Fritzell,Jelle Thole,Carlos Martín,Thomas Scriba,Mark Hatherill

Statistical Analysis Plan

2019

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.

Keywords:

Tuberculosis
BCG vaccine
Statistical Analysis Plan
Pediatrics
Medicine
Immunogenicity
Reactogenicity
Clinical trial

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