title: 2-Year Efficacy, Immunogenicity, and Safety of Vigoo Enterovirus 71 Vaccine in Healthy Chinese Children: A Randomized Open-Label Study.
abstract: BACKGROUND
  This study evaluated the 2-year efficacy, immunogenicity, and safety of the Vigoo enterovirus 71 (EV71) vaccine.
  
  
  METHODS
  In an initial phase 3 study, we randomly assigned healthy infants and children aged 6-35 months (ratio, 1:1) to receive 2 doses of either EV71 vaccine (5120 participants) or placebo (5125 participants) at days 0 and 28, and followed them for 12 months after vaccination. In this extended follow-up study, we continued to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine for up to 2 years.
  
  
  RESULTS
  Overall efficacy was 94.84% (95% confidence interval [CI], 83.53%-98.38%) during the 2-year follow-up period (P < .0001), and the vaccine efficacy during the second year was 100.00% (95% CI, 84.15%-100.00%) against EV71-associated hand-foot-and-mouth disease (HFMD; P < .0001). Geometric mean titers of neutralizing antibody in participants remained high during the 2-year follow-up period, and no vaccine-related serious adverse events were recorded.
  
  
  CONCLUSIONS
  Two doses of Vigoo EV71 vaccine could provide sustained protection against EV71-associated HFMD in healthy Chinese children.
  
  
  BACKGROUND
  NCT01508247.
authors.affiliation: Department of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University.
authors.forename: Mingwei
authors.initials: M
authors.lastname: Wei
authors.affiliation: Jiangsu Province Center for Disease Control and Prevention.
authors.forename: Fanyue
authors.initials: F
authors.lastname: Meng
authors.affiliation: School of Public Health, Southeast University, Nanjing.
authors.forename: Shiyuan
authors.initials: S
authors.lastname: Wang
authors.affiliation: Jiangsu Province Center for Disease Control and Prevention.
authors.forename: Jingxin
authors.initials: J
authors.lastname: Li
authors.affiliation: Beijing Vigoo Biological.
authors.forename: Yuntao
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: National Institute for Food and Drug Control.
authors.forename: Qunying
authors.initials: Q
authors.lastname: Mao
authors.affiliation: Jiangsu Province Center for Disease Control and Prevention.
authors.forename: Yuemei
authors.initials: Y
authors.lastname: Hu
authors.affiliation: School of Public Health, Southeast University, Nanjing.
authors.forename: Pei
authors.initials: P
authors.lastname: Liu
authors.affiliation: Chaoyang District Center for Disease Control and Prevention, Beijing, China.
authors.forename: Nianmin
authors.initials: N
authors.lastname: Shi
authors.affiliation: Jiangsu Province Center for Disease Control and Prevention.
authors.forename: Hong
authors.initials: H
authors.lastname: Tao
authors.affiliation: Jiangsu Province Center for Disease Control and Prevention.
authors.forename: Kai
authors.initials: K
authors.lastname: Chu
authors.affiliation: School of Public Health, Southeast University, Nanjing.
authors.forename: Yuxiao
authors.initials: Y
authors.lastname: Wang
authors.affiliation: National Institute for Food and Drug Control.
authors.forename: Zhenglun
authors.initials: Z
authors.lastname: Liang
authors.affiliation: Beijing Vigoo Biological.
authors.forename: Xiuling
authors.initials: X
authors.lastname: Li
authors.affiliation: Department of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University.|Jiangsu Province Center for Disease Control and Prevention.
authors.forename: Fengcai
authors.initials: F
authors.lastname: Zhu
mesh_terms: D000818:Animals; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002675:Child, Preschool; D002681:China; D004311:Double-Blind Method; D029821:Enterovirus A, Human / Q000276:immunology*; D004769:Enterovirus Infections / Q000276:immunology* / Q000517:prevention & control* / Q000821:virology; D005500:Follow-Up Studies; D005536:Foot-and-Mouth Disease / Q000276:immunology / Q000517:prevention & control; D006801:Humans; D007115:Immunization Schedule; D000071497:Immunogenicity, Vaccine; D007223:Infant; D013997:Time Factors; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology; D014765:Viral Vaccines / Q000009:adverse effects* / Q000276:immunology*
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D015164:Vaccines, Inactivated; D014765:Viral Vaccines
keywords: Vigoo enterovirus 71 vaccine; efficacy; hand, foot, and mouth disease; immunogenicity; safety