{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T23:43:13Z","timestamp":1793835793403,"version":"4.6.1"},"reference-count":25,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2025,9,13]],"date-time":"2025-09-13T00:00:00Z","timestamp":1757721600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Sinovac Life Sciences Co., Ltd. (Beijing, China)"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background: The persistence of non-neonatal tetanus (non-NT) highlights the necessity of adult booster vaccines and post-traumatic prophylaxis. This Phase I\/III clinical trial aimed to evaluate the safety and immunogenicity of a new adsorbed tetanus vaccine. Methods: A randomized, double-blind, positive-controlled clinical trial was conducted in Henan Province, China. A total of 1258 healthy participants aged 18\u201344 years (60 in Phase I and 1198 in Phase III) were enrolled, with no history of tetanus infection, or tetanus toxoid-containing vaccines (TTCVs) vaccination within the past 10 years. The participants were randomly assigned at a 1:1 ratio to receive a single dose of either the investigational vaccine or the licensed control vaccine. The Phase III clinical trial was initiated subsequent to the 7-day safety observation period following vaccination in the Phase I trial. The objective of the Phase III clinical trial was to assess the non-inferiority of the seroconversion rate of tetanus antibodies at 30 days post-vaccination with the investigational vaccine compared to the control vaccine. Serum samples were collected prior to and at 30 days post-vaccination. Adverse events were monitored for 30 days, with serious adverse events (SAEs) followed up for 6 months post-vaccination. Results: The investigational group achieved a seroconversion rate of 99.48%, which was non-inferior to that of the control group (99.66%), with a negligible rate difference of \u22120.17% (95% confidence interval [CI]: \u22121.20%, 0.78%). The investigational group exhibited a significantly higher geometric mean concentration (GMC) of antibodies (4.721 IU\/mL vs. 3.627 IU\/mL, p &lt; 0.0001). Among the susceptible participants, the seroconversion rates were 99.78% in the investigational group and 99.79% in the control group, respectively, with a non-inferior rate difference of \u22120.01% (95%CI: \u22121.06%, 0.97%). Furthermore, the investigational group showed a low incidence of adverse reactions (ARs) within 30 days post-vaccination (12.26%), which was comparable to that of the control group (13.65%). All the reported ARs were mild or moderate, and no SAEs were associated with the vaccination. Conclusions: The new adsorbed tetanus vaccine demonstrated favorable safety and comparable immunogenicity to the marketed control vaccine, with a significantly higher antibody GMC, supporting its clinical application in tetanus prevention.<\/jats:p>","DOI":"10.3390\/vaccines13090972","type":"journal-article","created":{"date-parts":[[2025,9,16]],"date-time":"2025-09-16T08:56:46Z","timestamp":1758013006000},"page":"972","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Safety and Immunogenicity of Single-Dose of Adsorbed Tetanus Vaccine in Adults Aged 18\u201344 Years: Randomized, Double-Blind, Positive-Controlled Phase I\/III Clinical Trial"],"prefix":"10.3390","volume":"13","author":[{"given":"Zhiqiang","family":"Xie","sequence":"first","affiliation":[{"name":"Henan Provincial Center for Disease Control and Prevention, Zhengzhou 450016, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liyong","family":"Yuan","sequence":"additional","affiliation":[{"name":"National Institutes for Food and Drug Control, Beijing 102629, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0386-1071","authenticated-orcid":false,"given":"Yaping","family":"Qiao","sequence":"additional","affiliation":[{"name":"Sinovac Holding Group Co., Ltd., Beijing 100085, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wangyang","family":"You","sequence":"additional","affiliation":[{"name":"Henan Provincial Center for Disease Control and Prevention, Zhengzhou 450016, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6851-0435","authenticated-orcid":false,"given":"Yurong","family":"Li","sequence":"additional","affiliation":[{"name":"Sinovac Holding Group Co., Ltd., Beijing 100085, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taotao","family":"Zhu","sequence":"additional","affiliation":[{"name":"Sinovac Holding Group Co., Ltd., Beijing 100085, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Zhang","sequence":"additional","affiliation":[{"name":"Henan Provincial Center for Disease Control and Prevention, Zhengzhou 450016, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lili","family":"Huang","sequence":"additional","affiliation":[{"name":"Henan Provincial Center for Disease Control and Prevention, Zhengzhou 450016, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiebing","family":"Tan","sequence":"additional","affiliation":[{"name":"Henan Provincial Center for Disease Control and Prevention, Zhengzhou 450016, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0895-2957","authenticated-orcid":false,"given":"Xiaocan","family":"Jia","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou 450001, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhe","family":"Li","sequence":"additional","affiliation":[{"name":"National Institutes for Food and Drug Control, Beijing 102629, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng","family":"Xue","sequence":"additional","affiliation":[{"name":"Sinovac Life Sciences Co., Ltd., Beijing 102601, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaojuan","family":"Lian","sequence":"additional","affiliation":[{"name":"Sinovac Holding Group Co., Ltd., Beijing 100085, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanxia","family":"Wang","sequence":"additional","affiliation":[{"name":"Henan Provincial Center for Disease Control and Prevention, Zhengzhou 450016, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,9,13]]},"reference":[{"key":"ref_1","unstructured":"National Health Commission of the People\u2019s Republic of China (2025, July 23). 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