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

• DOI: 10.1016/j.lanwpc.2021.100284
• Publication Date: 2021-11-03T06:42:34Z
• Authors: Yan Li; Fan Gao; Yamin Wang; Jing Li; Yuxi Zhang; Huakun Lv; Shenyu Wang; Haitao Yang; Xiaoqiang Liu; Keli Li; Huaqing Wang; Zundong Yin; Zhenglun Liang; Zhijie An; Qunying Mao; Zijian Feng
• Keywords: Enterovirus 71; Inactivated vaccine

BackgroundChina's three inactivated enterovirus A71 (EV-A71) vaccines are the first and currently world's only EV-A71 approved by a national regulatory authority used to prevent associated diseases. The vary vaccine strain, manufacturing cell substrate, antigen dose, but no head-to-head comparisons of these have been done. We compared immunogenicity in children 6-35 months old.MethodsWe recruited healthy aged who lived study site county into multicentre, open-label, non-inferiority, three-group, randomised controlled trial that was conducted five counties China. Enrolled were randomly assigned (1:1:1) receive two doses one vaccines. primary outcome proportion with neutralizing antibody seroconversion 4 weeks after second dose; secondary adverse events each dose. Analyses included all completed (per-protocol analysis). Safety analysis safety follow-up at least one. 10% margin establish non-inferiority. This registered on World Health Organization platform: Chinese Clinical Trial Registry (ChiCTR1900026663).Findings1631 assessed for eligibility between Nov 20, 2019. Of 1500 (92%) enrolled children, 500 group A, B, or C; 483 A,484 487 C study. Before dose one, seropositive rates groups 9.7%, 7.2%, 7.0%. Four 98.8%, 99.4% 99.8% - mutually non-inferior two-group comparisons. There serious any evidence difference among incidence local event systemic event. Fever most common All reported recovered.InterpretationNon-inferior high equivalent supports use EV-A71-associated These results may be useful regulators, policy makers, immunization programmes China countries where is endemic.