Immunogenicity and safety of inactivated enterovirus A71 vaccines in children aged 6-35 months in China: a non-inferiority, randomised controlled trial.

ABSTRACT:

Background

China's three inactivated enterovirus A71 (EV-A71) vaccines are the first and currently world's only EV-A71 vaccines approved by a national regulatory authority and used to prevent EV-A71 associated diseases. The three vaccines vary by vaccine strain, manufacturing cell substrate, and antigen dose, but no head-to-head comparisons of these vaccines have been done. We compared immunogenicity of the vaccines in children 6-35 months old.

Methods

We recruited healthy children aged 6-35 months who lived in a study site county into a multicentre, open-label, non-inferiority, three-group, randomised controlled trial that was conducted in five counties in China. Enrolled children were randomly assigned (1:1:1) to receive two doses of one of the three EV-A71 vaccines. The p

SUBMITTER: Li Y 

PROVIDER: S-EPMC8579145 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature