title: Phase 3 Trial of a Sabin Strain-Based Inactivated Poliovirus Vaccine.
abstract: BACKGROUND
  The development of a Sabin strain-based inactivated poliovirus vaccine (Sabin-IPV) is imperative to protecting against vaccine-associated paralytic poliomyelitis in developing countries.
  
  
  METHODS
  In this double-blinded, parallel-group, noninferiority trial, eligible infants aged 60-90 days were randomly assigned in a ratio of 1:1 to receive either 3 doses of Sabin-IPV or Salk strain-based IPV (Salk-IPV) at 30-day intervals and a booster at the age of 18 months. Immunogenicity and safety were assessed on the basis of a protocol.
  
  
  RESULTS
  Of 1438 infants, 1200 eligible infants were recruited and received either Sabin-IPV or Salk-IPV. From the Sabin-IPV and Salk-IPV groups, 570 and 564 infants, respectively, completed the primary immunization and formed the per-protocol population. The seroconversion rates of the participants who received Sabin-IPV were 100%, 94.9%, and 99.0% (types I, II, and III, respectively), and those of the participants who received Salk-IPV were 94.7%, 91.3%, and 97.9% 1 month after the completion of primary immunization. An anamnestic response for poliovirus types I, II, and III was elicited by a booster in both groups. Except in the case of fever, other adverse events were similar between the 2 groups.
  
  
  CONCLUSIONS
  The immune response induced by Sabin-IPV was not inferior to that established with Salk-IPV.
authors.affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming.
authors.forename: Guoyang
authors.initials: G
authors.lastname: Liao
authors.affiliation: Guangxi Province Center for Disease Control and Prevention, Nanning.
authors.forename: Rongcheng
authors.initials: R
authors.lastname: Li
authors.affiliation: National Institutes for Food and Drug Control, Beijing.
authors.forename: Changgui
authors.initials: C
authors.lastname: Li
authors.affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming.
authors.forename: Mingbo
authors.initials: M
authors.lastname: Sun
authors.affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming.
authors.forename: Shude
authors.initials: S
authors.lastname: Jiang
authors.affiliation: Guangxi Province Center for Disease Control and Prevention, Nanning.
authors.forename: Yanping
authors.initials: Y
authors.lastname: Li
authors.affiliation: Guangxi Province Center for Disease Control and Prevention, Nanning.
authors.forename: Zhaojun
authors.initials: Z
authors.lastname: Mo
authors.affiliation: Department of Health Statistics, Fourth Military Medical University, Xi'an, China.
authors.forename: Jielai
authors.initials: J
authors.lastname: Xia
authors.affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming.
authors.forename: Zhongping
authors.initials: Z
authors.lastname: Xie
authors.affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming.
authors.forename: Yanchun
authors.initials: Y
authors.lastname: Che
authors.affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming.
authors.forename: Jingsi
authors.initials: J
authors.lastname: Yang
authors.affiliation: National Institutes for Food and Drug Control, Beijing.
authors.forename: Zhifang
authors.initials: Z
authors.lastname: Yin
authors.affiliation: National Institutes for Food and Drug Control, Beijing.
authors.forename: Jianfeng
authors.initials: J
authors.lastname: Wang
authors.affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming.
authors.forename: Jiayou
authors.initials: J
authors.lastname: Chu
authors.affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming.
authors.forename: Wei
authors.initials: W
authors.lastname: Cai
authors.affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming.
authors.forename: Jian
authors.initials: J
authors.lastname: Zhou
authors.affiliation: National Institutes for Food and Drug Control, Beijing.
authors.forename: Junzhi
authors.initials: J
authors.lastname: Wang
authors.affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming.
authors.forename: Qihan
authors.initials: Q
authors.lastname: Li
mesh_terms: D000914:Antibodies, Viral / Q000097:blood*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D011051:Poliomyelitis / Q000517:prevention & control*; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D011054:Poliovirus Vaccine, Inactivated
keywords: Sabin strain; inactivated vaccine; poliovirus