An evaluation of a test-negative design for EV-71 vaccine from a randomized controlled trial.

ABSTRACT: Background: The test-negative design has been used widely in evaluation of various vaccines' effectiveness, such as influenza, rotavirus, and so on. Recently, there have been some studies about EV-71 vaccine effectiveness by using test-negative design(TND). However, the validity of the TND application in EV-71 vaccines has not been evaluated.Methods: This study is set upon prior methods to evaluate the validity of TND for influenza vaccine by using a randomized controlled clinical trial database. Vaccine effectiveness estimated by TND (VE-TND) in modified intention-to-treat population (mITT) and per-protocol-set population(PPS) was derived from a large randomized placebo-controlled clinical trial (RCT) of inactivated monovalent EV-71 vaccine in China. Derived VE-TND estimates

SUBMITTER: Zhang L 

PROVIDER: S-EPMC8189103 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature