Official Study Title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Assess the Prophylactic Efficacy, Safety, and Immunogenicity of the Investigational M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine When Administered Intramuscularly on a 0,1-month Schedule to Adolescents and Adults.

Biological Intervention

M72/AS01E-4 Mycobacterium tuberculosis investigational vaccine. On Day 1 and Day 29, participants will receive an intramuscular dose of M72 (recombinant fusion protein) reconstituted with AS01E-4 (an adjuvant system).

Primary Outcome Measures

IGRA-Positive Cohort: Number of participants with laboratory-confirmed pulmonary TB. Time Frame: Up to Month 49. Laboratory-confirmed pulmonary TB case is defined as a participant with suspected pulmonary TB presenting with one or more of the following signs or symptoms: unexplained cough, unintentional weight loss, hemoptysis, unexplained fever, night sweats, pleuritic chest pain; who has least 2 positive Mtb test results (positive Mtb culture and/or positive test result from Xpert Ultra or similar assay, excluding "trace positive"), from the same or from different sputum samples collected during the 3 suspected TB visits, preferably within a 7-day time frame, before initiation of TB treatment.