Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain

Summary

A randomized and blind clinical consistency study for three commercial batches of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV) for immunogenicity and safety evaluation.

Timeline

Start

2018-04-15

Primary completion

2019-02-25

Completion

2019-10-12

Outcome

Met primary endpoint

paper In conclusion, sIPV exhibits good lot-to-lot consistency and safety in large-scale populations PMID 33487470 ↗

Publications

• Yin Q, Zheng Y, Ying Z, Li J, Jiang Y, Bao W, Dou Y, Pu Y, Lei J, Yang H, Jiang R, Deng Y, Zhao Z, Pu J, Yang J, Li Y, Xu M, Cai W, Che Y, Shi L. Quantitative Analysis of the Instant and Persistent Inhibition Effects of Maternal Poliovirus Antibodies on the Immune Response in a Phase IV Trial of a Sabin Strain-Based Inactivated Poliovirus Vaccine. Vaccines (Basel). 2024 Feb 19;12(2):217. doi: 10.3390/vaccines12020217.
• Yin Q, Zheng Y, Ying Z, Li J, Jiang Y, Bao W, Dou Y, Pu Y, Lei J, Yang H, Jiang R, Deng Y, Zhao Z, Pu J, Yang J, Li Y, Xu M, Cai W, Che Y, Shi L. Immunogenicity and lot-to-lot consistency of booster shot with Sabin inactivated poliomyelitis vaccine in Chinese children aged 18-24 Months: A phase Ⅳ clinical trial. Vaccine. 2024 Mar 19;42(8):1973-1979. doi: 10.1016/j.vaccine.2024.02.042. Epub 2024 Feb 21.
• Jiang R, Liu X, Sun X, Wang J, Huang Z, Li C, Li Z, Zhou J, Pu Y, Ying Z, Yin Q, Zhao Z, Zhang L, Lei J, Bao W, Jiang Y, Dou Y, Li J, Yang H, Cai W, Deng Y, Che Y, Shi L, Sun M. Immunogenicity and safety of the inactivated poliomyelitis vaccine made from Sabin strains in a phase IV clinical trial for the vaccination of a large population. Vaccine. 2021 Mar 1;39(9):1463-1471. doi: 10.1016/j.vaccine.2021.01.027. Epub 2021 Jan 22.

Drugs

Indications