{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T00:36:11Z","timestamp":1759970171096,"version":"build-2065373602"},"reference-count":21,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2025,1,7]],"date-time":"2025-01-07T00:00:00Z","timestamp":1736208000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Sinocelltech Ltd.","award":["Z231100004823003","2023YFC3042100","2022YFC0870600"],"award-info":[{"award-number":["Z231100004823003","2023YFC3042100","2022YFC0870600"]}]},{"DOI":"10.13039\/501100012401","name":"Beijing Science and Technology Planning Project","doi-asserted-by":"publisher","award":["Z231100004823003","2023YFC3042100","2022YFC0870600"],"award-info":[{"award-number":["Z231100004823003","2023YFC3042100","2022YFC0870600"]}],"id":[{"id":"10.13039\/501100012401","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100012166","name":"National Key Research and Development Program of China","doi-asserted-by":"publisher","award":["Z231100004823003","2023YFC3042100","2022YFC0870600"],"award-info":[{"award-number":["Z231100004823003","2023YFC3042100","2022YFC0870600"]}],"id":[{"id":"10.13039\/501100012166","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background: SCTV01E is a tetravalent recombinant COVID-19 vaccine authorized for emergency use in China for adults 18 years and older but not for those under 18. Objective: This Phase 2 trial assessed the safety and immunogenicity of SCTV01E in healthy children and adolescents aged 3 to 17 years, to establish immunobridging with that observed in adults from the efficacy pivotal trial (NCT05308576). Methods: Participants were randomly assigned to receive either 30 \u00b5g of SCTV01E or a placebo. Primary endpoints were safety and immunogenicity focused on the geometric mean titer (GMT) and seroresponse rate (SRR) of neutralizing antibodies (nAb) against Omicron BA.5. Results: In total, 268 participants (214 SCTV01E vs. 54 placebo) were included in the safety analysis, with 241 participants (191 vs. 50) in the immunogenicity analysis. Overall, 127 (59.3%) participants receiving SCTV01E and 9 (16.7%) receiving a placebo reported adverse events (AEs), most of which were Grade 1 or 2. No serious adverse events (SAEs) or adverse events of special interest (AESIs) were reported. In the immunogenicity bridging analysis, data from 95 youths were compared with data from 188 adults; the geometric mean ratio (GMR) of the titers was 8.78 (95% CI: 6.05\u201312.74, p &lt; 0.001), with the lower bound of the 95% CI exceeding 0.67. The difference in the SRR was 6.34% (95% CI: 0.93\u201311.22%) (p = 0.029), and the lower bound of the 95%CI was &gt;\u22125%, indicating superiority. Conclusions: SCTV01E was found to be safe and well tolerated in children and adolescents, generating a robust immune response against Omicron BA.5. This supports its potential use in younger populations.<\/jats:p>","DOI":"10.3390\/vaccines13010043","type":"journal-article","created":{"date-parts":[[2025,1,7]],"date-time":"2025-01-07T05:06:34Z","timestamp":1736226394000},"page":"43","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety and Immunogenicity of the Tetravalent Recombinant COVID-19 Protein Vaccine SCTV01E in Children and Adolescents Aged 3 to 17 Years: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial"],"prefix":"10.3390","volume":"13","author":[{"given":"Fengcai","family":"Zhu","sequence":"first","affiliation":[{"name":"Jiangsu Provincial Center for Disease Control and Prevention, Jiangsu Provincial Academy of Preventive Medicine, Nanjing 210009, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ting","family":"Huang","sequence":"additional","affiliation":[{"name":"Sichuan Center for Disease Prevention and Control, Chengdu 610041, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pengfei","family":"Jin","sequence":"additional","affiliation":[{"name":"Jiangsu Provincial Center for Disease Control and Prevention, Jiangsu Provincial Academy of Preventive Medicine, Nanjing 210009, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Linglin","family":"Zhang","sequence":"additional","affiliation":[{"name":"Sichuan Center for Disease Prevention and Control, Chengdu 610041, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhongqiang","family":"Jin","sequence":"additional","affiliation":[{"name":"Sichuan Center for Disease Prevention and Control, Chengdu 610041, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wenli","family":"Zhang","sequence":"additional","affiliation":[{"name":"Sichuan Center for Disease Prevention and Control, Chengdu 610041, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dongya","family":"Yuan","sequence":"additional","affiliation":[{"name":"Dazhu County Disease Prevention Control Center, Dazhu 635199, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhong","family":"Wang","sequence":"additional","affiliation":[{"name":"Dazhu County Disease Prevention Control Center, Dazhu 635199, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yusong","family":"Deng","sequence":"additional","affiliation":[{"name":"Dazhu County Disease Prevention Control Center, Dazhu 635199, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiaxin","family":"Li","sequence":"additional","affiliation":[{"name":"Dazhu County Disease Prevention Control Center, Dazhu 635199, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiao","family":"Shen","sequence":"additional","affiliation":[{"name":"Dazhu County Disease Prevention Control Center, Dazhu 635199, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yongpan","family":"Fu","sequence":"additional","affiliation":[{"name":"Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jian","family":"Li","sequence":"additional","affiliation":[{"name":"Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4537-5303","authenticated-orcid":false,"given":"Xinjie","family":"Yang","sequence":"additional","affiliation":[{"name":"Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jing","family":"Li","sequence":"additional","affiliation":[{"name":"Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4504-7622","authenticated-orcid":false,"given":"Liangzhi","family":"Xie","sequence":"additional","affiliation":[{"name":"Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, China"},{"name":"Cell Culture Engineering Center, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100006, China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,1,7]]},"reference":[{"key":"ref_1","unstructured":"WHO (2024, September 03). 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