{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T08:35:21Z","timestamp":1793954121036,"version":"4.8.0"},"reference-count":16,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2025,10,24]],"date-time":"2025-10-24T00:00:00Z","timestamp":1761264000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>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 \u201c2IPV + 1bOPV\u201d 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 &lt; 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.<\/jats:p>","DOI":"10.3390\/vaccines13111094","type":"journal-article","created":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T00:51:42Z","timestamp":1761526302000},"page":"1094","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["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"],"prefix":"10.3390","volume":"13","author":[{"given":"Yafei","family":"Liu","sequence":"first","affiliation":[{"name":"Beijing Minhai Biotechnology Co., Ltd., Beijing 102600, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2117-765X","authenticated-orcid":false,"given":"Xiaodong","family":"Liu","sequence":"additional","affiliation":[{"name":"Shandong Center for Disease Control and Prevention, Jinan 250014, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Zhang","sequence":"additional","affiliation":[{"name":"Shandong Center for Disease Control and Prevention, Jinan 250014, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xianyun","family":"Chang","sequence":"additional","affiliation":[{"name":"Beijing Minhai Biotechnology Co., Ltd., Beijing 102600, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ping","family":"Xiong","sequence":"additional","affiliation":[{"name":"Shandong Center for Disease Control and Prevention, Jinan 250014, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanxin","family":"Guan","sequence":"additional","affiliation":[{"name":"Beijing Minhai Biotechnology Co., Ltd., Beijing 102600, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yixin","family":"Li","sequence":"additional","affiliation":[{"name":"Beijing Minhai Biotechnology Co., Ltd., Beijing 102600, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weiling","family":"Zhang","sequence":"additional","affiliation":[{"name":"Daiyue District Center for Disease Control and Prevention, Taian 271000, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lili","family":"Xuan","sequence":"additional","affiliation":[{"name":"Daiyue District Center for Disease Control and Prevention, Taian 271000, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Li","sequence":"additional","affiliation":[{"name":"Daiyue District Center for Disease Control and Prevention, Taian 271000, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhifang","family":"Ying","sequence":"additional","affiliation":[{"name":"National Institute for Food and Drug Control, Beijing 102629, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qing","family":"Xu","sequence":"additional","affiliation":[{"name":"Shandong Center for Disease Control and Prevention, Jinan 250014, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,10,24]]},"reference":[{"key":"ref_1","unstructured":"Concepcion, F.E., Ruth, L., and Tom, S. 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Dis."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"7188","DOI":"10.1016\/j.vaccine.2011.05.079","article-title":"Inactivated polio vaccine development for technology transfer using attenuated Sabin poliovirus strains to shift from Salk-IPV to Sabin-IPV","volume":"29","author":"Bakker","year":"2011","journal-title":"Vaccine"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"2324538","DOI":"10.1080\/21645515.2024.2324538","article-title":"A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China","volume":"20","author":"Chen","year":"2024","journal-title":"Hum. Vaccines Immunother."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"6274","DOI":"10.1016\/j.vaccine.2020.07.042","article-title":"Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China","volume":"38","author":"Yan","year":"2020","journal-title":"Vaccine"}],"container-title":["Vaccines"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2076-393X\/13\/11\/1094\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,28]],"date-time":"2025-10-28T05:24:26Z","timestamp":1761629066000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2076-393X\/13\/11\/1094"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,24]]},"references-count":16,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2025,11]]}},"alternative-id":["vaccines13111094"],"URL":"https:\/\/doi.org\/10.3390\/vaccines13111094","relation":{},"ISSN":["2076-393X"],"issn-type":[{"value":"2076-393X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,24]]}}}