A comparison of the test-negative and the matched case-control study designs for estimation of EV71 vaccine immunological surrogate endpoints from a randomized controlled trial.

ABSTRACT: Since TND could be an appropriate method to assess vaccine effectiveness, we want to know whether it may be used for the estimation of vaccine immunological surrogate endpoints, like case-control study. We conducted two study designs (test-negative design (TND) VS matched case-control design (MCC)) to evaluate immunological surrogate endpoint against EV71-associated diseases. We calculated sensitivity (proportion of participants with EV71-associated disease who have a titer less than the cutoff at day 56), specificity (proportion of matched controls who have a titer equal or greater than the cutoff at day 56), and corresponding Youden index ([sensitivity + specificity] - 1). Then, we compared them between TND and MCC. In test-negative design, we totally enrolled 7029 subjects, 49 tested po

SUBMITTER: Zhang L 

PROVIDER: S-EPMC9481104 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature