↵# Co-first authors: Guoyang Liao, Rongcheng Li, Changgui Li, and Mingbo Sun contributed equally to this work. Shude Jiang was the PI responsible for the technical design for vaccine production.

Abstract below; full text is available to journal subscribers

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-blind, parallel-group, non-inferiority trial, eligible infants aged 60-90 days were randomly assigned in a ratio of 1:1 to receive either three doses of Sabin-IPV or Salk-IPV at 30-day intervals and a booster at the age of 18 months. Immunogenicity and safety were assessed based on 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% at one 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 two groups.

Conclusion. The immune response induced by Sabin-IPV was not inferior to that established with Salk-IPV.

UNCORRECTED PROOF