{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T03:28:50Z","timestamp":1782876530985,"version":"3.54.5"},"reference-count":20,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2024,5,24]],"date-time":"2024-05-24T00:00:00Z","timestamp":1716508800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"The Company for Vaccine and Biological Production No. 1 (VABIOTECH), Ministry of Health","award":["126\/Q\u0110-TNLS-VBIOTECH"],"award-info":[{"award-number":["126\/Q\u0110-TNLS-VBIOTECH"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Viruses"],"abstract":"<jats:p>Objective: This study aims to evaluate the safety and immunogenicity of the SKYVaricella vaccine in healthy Vietnamese children aged 12 months to 12 years. Methods: This open-label, single-arm study involved 201 children divided into two groups: 60 children aged 12 months to 5 years and 141 children aged 6 to 12 years. Safety was assessed through immediate reactions, solicited adverse events within 7 days, and unsolicited events up to Day 42. Immunogenicity was evaluated by seroconversion rates (SCR) and geometric mean titer (GMT) increments using fluorescent antibody-to-membrane antigen (FAMA) on the day of vaccination (D0) and 42 days after vaccination (D42). Results: All participants completed the follow-up. Immediate adverse events included pain (8.0%), redness (8.0%), and swelling (20.9%) at the injection site. Within 7 days, pain (17.9%) and swelling (12.4%) were mild and self-resolving. Unsolicited adverse events were infrequent and mild. Both age groups achieved 100% SCR. GMT of varicella-zoster virus antibodies increased from 1.37 (SD 1.97) at D0 to 18.02 (SD 2.22) at D42, a 13.12-fold rise. No Grade 3 adverse events were observed. Conclusion: The SKYVaricella vaccine shows a robust immunogenic response and favorable safety profile in Vietnamese children aged 12 months to 12 years. These findings endorse its potential inclusion in pediatric vaccination programs as a reliable preventive option against varicella.<\/jats:p>","DOI":"10.3390\/v16060841","type":"journal-article","created":{"date-parts":[[2024,5,24]],"date-time":"2024-05-24T11:17:52Z","timestamp":1716549472000},"page":"841","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Safety and Immunogenicity of the Live Attenuated Varicella Vaccine in Vietnamese Children Aged 12 Months to 12 Years: An Open-Label, Single-Arm Bridging Study"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-7377-3109","authenticated-orcid":false,"given":"Pham Van","family":"Hung","sequence":"first","affiliation":[{"name":"The Company for Vaccine and Biological Production No. 1 (VABIOTECH), Ministry of Health, Hanoi 100000, Vietnam"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Le Thi Huong","family":"Giang","sequence":"additional","affiliation":[{"name":"The Company for Vaccine and Biological Production No. 1 (VABIOTECH), Ministry of Health, Hanoi 100000, Vietnam"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8326-388X","authenticated-orcid":false,"given":"Phung Lam","family":"Toi","sequence":"additional","affiliation":[{"name":"Health Strategy and Policy Institute, Ministry of Health, Hanoi 100000, Vietnam"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vu Thi Minh","family":"Thuc","sequence":"additional","affiliation":[{"name":"Tam Anh General Hospital, Hanoi 100000, Vietnam"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6644-7097","authenticated-orcid":false,"given":"Bui Dang The","family":"Anh","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Vietnam Military Medical University, Hanoi 100000, Vietnam"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0810-8521","authenticated-orcid":false,"given":"Dinh Cong","family":"Pho","sequence":"additional","affiliation":[{"name":"Department of Military Science, Vietnam Military Medical University, Hanoi 100000, Vietnam"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5458-8001","authenticated-orcid":false,"given":"Pham Ngoc","family":"Hung","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Vietnam Military Medical University, Hanoi 100000, Vietnam"},{"name":"Department of Education and Training, Vietnam Military Medical University, Hanoi 100000, Vietnam"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,5,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"728","DOI":"10.1128\/CMR.00052-13","article-title":"Pathogenesis and current approaches to control of varicella-zoster virus infections","volume":"26","author":"Gershon","year":"2013","journal-title":"Clin. 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