Information

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.

Bill and Melinda Gates Foundation – Medical Reseearch Institute

Type of Study

Collabolator

Clinical Trial (Vaccine)

Tuberculosis

Background

In the previously completed Phase 2b trial, the investigational M72/AS01E-4 Mtb vaccine conferred approximately 50% protection at 36 months (49.7%: 95% confidence interval [CI]: 2.1–74.2) against developing laboratory confirmed pulmonary tuberculosis disease (TB) when administered to adults who were IGRA-positive, and HIV-negative.

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