Immunogenicity and Safety of Sabin-IPV Replacement Vaccination

Phase 4 Completed 360 enrolled China National Biotec Group Company Limited Beijing Center for Disease Control and Prevention · collab Beijing Institute of Biological Products Co Ltd. · collab Peking University · collab

RandomizedParallel-groupSingle-blindPrevention

Summary

This study replaced the 2nd and 3rd dose of Salk-IPV (produced by Sanofi) with Sabin-IPV (produced by CNBG) and then reviewed the safety and immunogenicity of the vaccination, aiming to acquire scientific evidence for the feasibility of immunization involving different viral strains replacement.

Timeline

Start: 2018-03-01
Primary completion: 2018-12-28
Completion: 2020-08-31

Outcome

Met primary endpoint

paper post-immunization GMTs for all three types in the Salk-Sabin-Sabin group were not inferior to those in the Salk-Salk-Salk group (P < 0.001). PMID 33810904 ↗

paper The Salk-Sabin-Sabin IPV immunization schedule is not inferior to the Salk-Salk-Salk IPV schedule in terms of both immunogenicity and safety. PMID 33810904 ↗

Publications

Chen H, Gao Z, Bai S, Liu X, Han S, Xiao Y, Liu F, Yu Y, Sun H, Yang X. Immunogenicity and safety of sabin-strain based inactivated poliovirus vaccine replacing salk-strain based inactivated poliovirus vaccine: An innovative application of different strain-IPVs replacement. Vaccine. 2021 Apr 22;39(17):2467-2474. doi: 10.1016/j.vaccine.2021.02.073. Epub 2021 Mar 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Inactivated Polio Vaccine	Vaccine	—	—

Indications

No indication recorded.