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An evaluation of a test-negative design for EV-71 vaccine from a randomized controlled trial by Li Zhang; Mingwei Wei; Pengfei Jin; Jingxin Li; Fengcai Zhu is a Medicine article available to read on EtoBox.

What is An evaluation of a test-negative design for EV-71 vaccine from a randomized controlled trial about?

: 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.: 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 were compared to the original vaccine efficacy results in RCT (VE-RCT).: We totally enrolled 7325 participants who seeked medical care for suspected EV-71 infected diseases during the surveillance. There are no significant differences between cases(test-positive) and controls(test-negative) on sex, age, height, and weight. TND vaccine effectiveness estimates were similar to original RCT vaccine efficacy estimates, both in modi

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Author

Li Zhang; Mingwei Wei; Pengfei Jin; Jingxin Li; Fengcai Zhu

Publisher

Informa UK Limited

Published

2021

Language

EN

Field

Medicine (Health Sciences)