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Imprecision in tuberculosis infection outcomes; implications for non-inferiority vaccine trials

2025-06-20 infectious diseases Title + abstract only
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IntroductionRandomised trials comparing new vaccines against tuberculosis for use in neonates and infants, for whom Bacille Calmette-Guerin (BCG) vaccination is established practice, are using tuberculosis infection as the primary endpoint in a non-inferiority design. Markers of tuberculosis infection have imperfect sensitivity and specificity. Flaws in the non-inferiority trial design typically bias towards the null, which may result in falsely declaring non-inferiority. MethodsWe conducted a ...

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