Comparison of VPM1002 with BCG in the prevention of tuberculosis in newborn infants: a multicentre, double-blind, randomised, phase 3, non-inferiority trial

Study limitation reported by the research below: “The trial was terminated early due to fewer-than-expected QFT conversion events (334 of 632 planned), which substantially limits statistical power and the ability to draw definitive conclusions about vaccine efficacy.”