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Volume 13
Issue 11
10.3390/vaccines13111094
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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

Safety and Immunogenicity of sIPV in Healthy Infants Aged 2 Months Following Sequential Immunization Program Combination with bOPV: A Phase 3, Randomized, Blinded, Parallel Positive-Controlled Clinical Trial

by
Yafei Liu
1,†,
Xiaodong Liu
2,†,
Li Zhang
2,
Xianyun Chang
1,
Ping Xiong
2,
Yanxin Guan
1,
Yixin Li
1,
Weiling Zhang
3,
Lili Xuan
3,
Yan Li
3,
Zhifang Ying
4,* and
Qing Xu
2,*
1
Beijing Minhai Biotechnology Co., Ltd., Beijing 102600, China
2
Shandong Center for Disease Control and Prevention, Jinan 250014, China
3
Daiyue District Center for Disease Control and Prevention, Taian 271000, China
4
National Institute for Food and Drug Control, Beijing 102629, China
*
Authors to whom correspondence should be addressed.
†
These authors contributed equally to this work.
Vaccines 2025, 13(11), 1094; https://doi.org/10.3390/vaccines13111094 (registering DOI)
Submission received: 19 September 2025 / Revised: 14 October 2025 / Accepted: 18 October 2025 / Published: 24 October 2025
Versions Notes

Abstract

Objectives: This phase 3 clinical trial aimed to evaluate the safety and immunogenicity of the Sabin inactivated poliovirus vaccine (sIPV) manufactured by Biominhai in healthy infants following a sequential immunization regimen. Methods: A total of 300 healthy infants aged 2 months were randomly divided into the test group (sIPV-sIPV-bOPV) and the control group (wIPV-wIPV-bOPV) according to the ratio of 1:1. Both groups were inoculated under “2IPV + 1bOPV” schedule. Safety was assessed alongside poliovirus antibody levels before and after vaccination. Results: The overall incidence of adverse reactions (AEs) in the test and control groups was 44% and 39%, respectively. AEs in both groups primarily occurred following the first dose, with approximately 30% classified as grade 1 in severity. No significant differences were observed between groups regarding the incidence, severity, and symptoms of AEs. Additionally, no vaccine-related serious adverse events (SAEs) were reported. At 30 days after the last dose, the seroconversion rates of neutralizing antibodies against poliovirus types I and III reached 100% in both groups, while type II rates at 99% for the test group and 95% for the control. Notably, the seroconversion rates for all types in the test group were non-inferior to those in the control group. The geometric mean titers (GMTs) of neutralizing antibodies against poliovirus for type I (8622.64 vs. 2687.65), type II (207.73 vs. 54.06), and type III (2121.74 vs. 1699.12) were significantly higher in the test group (p < 0.0001 for type I and II; p = 0.04 for type III). Conclusions: The study concluded that the trial vaccine sIPV following sequential immunization program demonstrates good safety and immunogenicity, showing non-inferiority to the control vaccine.
Keywords: safety; immunogenicity; sIPV; bOPV; sequential immunization safety; immunogenicity; sIPV; bOPV; sequential immunization

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MDPI and ACS Style

Liu, Y.; Liu, X.; Zhang, L.; Chang, X.; Xiong, P.; Guan, Y.; Li, Y.; Zhang, W.; Xuan, L.; Li, Y.; et al. Safety and Immunogenicity of sIPV in Healthy Infants Aged 2 Months Following Sequential Immunization Program Combination with bOPV: A Phase 3, Randomized, Blinded, Parallel Positive-Controlled Clinical Trial. Vaccines 2025, 13, 1094. https://doi.org/10.3390/vaccines13111094

AMA Style

Liu Y, Liu X, Zhang L, Chang X, Xiong P, Guan Y, Li Y, Zhang W, Xuan L, Li Y, et al. Safety and Immunogenicity of sIPV in Healthy Infants Aged 2 Months Following Sequential Immunization Program Combination with bOPV: A Phase 3, Randomized, Blinded, Parallel Positive-Controlled Clinical Trial. Vaccines. 2025; 13(11):1094. https://doi.org/10.3390/vaccines13111094

Chicago/Turabian Style

Liu, Yafei, Xiaodong Liu, Li Zhang, Xianyun Chang, Ping Xiong, Yanxin Guan, Yixin Li, Weiling Zhang, Lili Xuan, Yan Li, and et al. 2025. "Safety and Immunogenicity of sIPV in Healthy Infants Aged 2 Months Following Sequential Immunization Program Combination with bOPV: A Phase 3, Randomized, Blinded, Parallel Positive-Controlled Clinical Trial" Vaccines 13, no. 11: 1094. https://doi.org/10.3390/vaccines13111094

APA Style

Liu, Y., Liu, X., Zhang, L., Chang, X., Xiong, P., Guan, Y., Li, Y., Zhang, W., Xuan, L., Li, Y., Ying, Z., & Xu, Q. (2025). Safety and Immunogenicity of sIPV in Healthy Infants Aged 2 Months Following Sequential Immunization Program Combination with bOPV: A Phase 3, Randomized, Blinded, Parallel Positive-Controlled Clinical Trial. Vaccines, 13(11), 1094. https://doi.org/10.3390/vaccines13111094

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