{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T02:02:53Z","timestamp":1792807373850,"version":"4.5.0"},"reference-count":27,"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 (Dalian) Vaccine Technology Co., Ltd.","id":[{"id":"https:\/\/ror.org\/047sh7442","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Objectives: The varicella vaccine (VarV) produced by Sinovac (Dalian) obtained World Health Organization (WHO) prequalification in November 2022. However, no direct comparative studies have been conducted between VarV and other WHO-prequalified varicella vaccines. The study aimed to assess the immunogenicity and safety of Sinovac\u2019s VarV compared with Merck Sharp &amp; Dohme\u2019s (MSD) VARIVAX\u00ae (Moorgate, London, UK) following a single dose administration. Methods: This Phase III, randomized, double-blind, active-controlled, non-inferiority trial was conducted in the Philippines. Healthy children aged 12 to 15 months were enrolled. Eligible participants were randomly assigned (1:1) to receive a single dose of varicella vaccine either manufactured by Sinovac (Test group) or MSD (Active control group). Immunogenicity was evaluated 6 weeks after vaccination by enzyme-linked immunosorbent assay (ELISA). The primary immunogenicity endpoint was seroresponse rate 6 weeks after vaccination. Seroresponse rate was defined as varicella-zoster virus (VZV) antibody concentration \u2265 10 mIU\/mL in participants who were seronegative (antibody concentration &lt; 10 mIU\/mL) at baseline. The secondary endpoint was the corresponding geometric mean concentration (GMC). Adverse events (AEs) and serious adverse events (SAEs) were monitored for 6 weeks after vaccination. Results: Among the 484 participants analyzed, the seroresponse rates 6 weeks after vaccination were 98.85% and 98.88% in the Test group and Active control group, respectively, with a difference of \u22120.03% (95% CI: \u22123.10%, 2.99%), which exceeded the predefined non-inferiority margin of \u221210%. The corresponding GMCs were 35.73 mIU\/mL and 37.34 mIU\/mL, respectively, with the ratio of 0.96 (95% CI: 0.86, 1.06), also exceeding the predefined non-inferiority margin of 0.67. Furthermore, the incidence of adverse reactions (ARs) in the Test group was lower than that in the Active control group (38.08% vs. 55.51%). Conclusions: Sinovac\u2019s VarV demonstrated non-inferior immunogenicity to WHO-prequalified comparator vaccine (VARIVAX\u00ae) and favorable safety profile. These findings indicated that VarV (Sinovac, Beijing, China) met WHO standards for varicella vaccine evaluation, supporting its global use consideration.<\/jats:p>","DOI":"10.3390\/vaccines13090973","type":"journal-article","created":{"date-parts":[[2025,9,16]],"date-time":"2025-09-16T08:56:46Z","timestamp":1758013006000},"page":"973","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Healthy Children Aged 12 to 15 Months: A Phase III, Randomized, Double-Blind, Active-Controlled Clinical Trial"],"prefix":"10.3390","volume":"13","author":[{"given":"Nancy","family":"Nazaire-Bermal","sequence":"first","affiliation":[{"name":"San Juan De Dios Educational Foundation, Inc-Hospital, Pasay City 1300, Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ningning","family":"Jia","sequence":"additional","affiliation":[{"name":"Sinovac Holding Group Co., Ltd., Beijing 100085, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Angela C.","family":"Maronilla","sequence":"additional","affiliation":[{"name":"San Juan De Dios Educational Foundation, Inc-Hospital, Pasay City 1300, Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-8209-5665","authenticated-orcid":false,"given":"Josemaria F.","family":"Lopez","sequence":"additional","affiliation":[{"name":"San Juan De Dios Educational Foundation, Inc-Hospital, Pasay City 1300, Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0385-8742","authenticated-orcid":false,"given":"Gang","family":"Zeng","sequence":"additional","affiliation":[{"name":"Sinovac Holding Group Co., Ltd., Beijing 100085, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenbin","family":"Wu","sequence":"additional","affiliation":[{"name":"Sinovac Holding Group Co., Ltd., Beijing 100085, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrielle Bernice C.","family":"Nimo","sequence":"additional","affiliation":[{"name":"San Juan De Dios Educational Foundation, Inc-Hospital, Pasay City 1300, Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chunfang","family":"Luan","sequence":"additional","affiliation":[{"name":"Sinovac (Dalian) Vaccine Technology Co., Ltd., Dalian 116620, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qianqian","family":"Xin","sequence":"additional","affiliation":[{"name":"Sinovac Holding Group Co., Ltd., Beijing 100085, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,9,13]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"2604","DOI":"10.1021\/acs.jchemed.2c00193","article-title":"Integrating Python into a Physical Chemistry Lab","volume":"99","year":"2022","journal-title":"J. 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