Immunogenicity and safety of a live attenuated varicella vaccine in children aged 1 to 12 years: A double-blind, randomized, parallel-controlled phase III clinical trial in China
Chickenpox outbreaks frequently occur in collective settings such as kindergartens and schools, posing a significant threat to children’s physical and mental health. This study aimed to evaluate the immunogenicity and safety of the freeze-dried live attenuated varicella vaccine (VarV) developed by B...
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Taylor & Francis Group
2025-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2025.2452681 |
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| author | Shiyuan Wang Yang Zhang Guifan Li Jinhui Shi Xianyun Chang Hao Zhang Fengcai Zhu Jingxin Li Kai Chu Jinfang Sun |
| author_facet | Shiyuan Wang Yang Zhang Guifan Li Jinhui Shi Xianyun Chang Hao Zhang Fengcai Zhu Jingxin Li Kai Chu Jinfang Sun |
| author_sort | Shiyuan Wang |
| collection | DOAJ |
| description | Chickenpox outbreaks frequently occur in collective settings such as kindergartens and schools, posing a significant threat to children’s physical and mental health. This study aimed to evaluate the immunogenicity and safety of the freeze-dried live attenuated varicella vaccine (VarV) developed by Beijing Minhai Biotechnology Co. LTD. in healthy participants aged 1–12 years. In this phase III, single-center, randomized, double-blind, active-controlled trial,1,200 healthy participants randomly assigned in a 1:1 ratio to receive one dose of either the test vaccine or the active control vaccine. Venous blood samples were collected before vaccination and 42 days after vaccination, and the fluorescent antibody to membrane antigen (FAMA) assay was used to detect VZV antibody. Adverse events (AEs) observed within 42 days after vaccination and serious adverse events (SAEs) within six months after vaccination were recorded. The seroconversion rates in the test and control groups were 96.79% and 96.43%, respectively, with a difference of 0.36% (95% CI, −1.76%–2.48%). The geometric mean titers (GMTs) were 61.74 and 58.04, respectively, with a difference of 1.06 (95% CI, 0.92–1.23). The lower limits of the 95% CI for the differences in seroconversion rates and GMT ratios between the two groups were greater than their respective pre-set non-inferiority margins. The overall incidence of AEs (p = .0112) in the test group was significantly lower than that in the control group. The freeze-dried live attenuated VarV developed by Beijing Minhai Biotechnology Co. LTD. demonstrated good immunogenicity and higher safety compared to the active control vaccine in healthy participants aged 1–12 years. |
| format | Article |
| id | doaj-art-e0290780ecaf4a61ab1d5862762dd9a0 |
| institution | Kabale University |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-e0290780ecaf4a61ab1d5862762dd9a02025-02-03T06:42:12ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2025.2452681Immunogenicity and safety of a live attenuated varicella vaccine in children aged 1 to 12 years: A double-blind, randomized, parallel-controlled phase III clinical trial in ChinaShiyuan Wang0Yang Zhang1Guifan Li2Jinhui Shi3Xianyun Chang4Hao Zhang5Fengcai Zhu6Jingxin Li7Kai Chu8Jinfang Sun9Department of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, PR ChinaDepartment of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, PR ChinaRegistration Department, Beijing Minhai Biotechnology Co., Ltd, BeiJing, ChinaRegistration Department, Beijing Minhai Biotechnology Co., Ltd, BeiJing, ChinaRegistration Department, Beijing Minhai Biotechnology Co., Ltd, BeiJing, ChinaRegistration Department, Beijing Minhai Biotechnology Co., Ltd, BeiJing, ChinaVaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, PR ChinaVaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, PR ChinaVaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, PR ChinaDepartment of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, PR ChinaChickenpox outbreaks frequently occur in collective settings such as kindergartens and schools, posing a significant threat to children’s physical and mental health. This study aimed to evaluate the immunogenicity and safety of the freeze-dried live attenuated varicella vaccine (VarV) developed by Beijing Minhai Biotechnology Co. LTD. in healthy participants aged 1–12 years. In this phase III, single-center, randomized, double-blind, active-controlled trial,1,200 healthy participants randomly assigned in a 1:1 ratio to receive one dose of either the test vaccine or the active control vaccine. Venous blood samples were collected before vaccination and 42 days after vaccination, and the fluorescent antibody to membrane antigen (FAMA) assay was used to detect VZV antibody. Adverse events (AEs) observed within 42 days after vaccination and serious adverse events (SAEs) within six months after vaccination were recorded. The seroconversion rates in the test and control groups were 96.79% and 96.43%, respectively, with a difference of 0.36% (95% CI, −1.76%–2.48%). The geometric mean titers (GMTs) were 61.74 and 58.04, respectively, with a difference of 1.06 (95% CI, 0.92–1.23). The lower limits of the 95% CI for the differences in seroconversion rates and GMT ratios between the two groups were greater than their respective pre-set non-inferiority margins. The overall incidence of AEs (p = .0112) in the test group was significantly lower than that in the control group. The freeze-dried live attenuated VarV developed by Beijing Minhai Biotechnology Co. LTD. demonstrated good immunogenicity and higher safety compared to the active control vaccine in healthy participants aged 1–12 years.https://www.tandfonline.com/doi/10.1080/21645515.2025.2452681Varicella vaccinechickenpoxpediatricphase IIIimmunogenicitysafety |
| spellingShingle | Shiyuan Wang Yang Zhang Guifan Li Jinhui Shi Xianyun Chang Hao Zhang Fengcai Zhu Jingxin Li Kai Chu Jinfang Sun Immunogenicity and safety of a live attenuated varicella vaccine in children aged 1 to 12 years: A double-blind, randomized, parallel-controlled phase III clinical trial in China Human Vaccines & Immunotherapeutics Varicella vaccine chickenpox pediatric phase III immunogenicity safety |
| title | Immunogenicity and safety of a live attenuated varicella vaccine in children aged 1 to 12 years: A double-blind, randomized, parallel-controlled phase III clinical trial in China |
| title_full | Immunogenicity and safety of a live attenuated varicella vaccine in children aged 1 to 12 years: A double-blind, randomized, parallel-controlled phase III clinical trial in China |
| title_fullStr | Immunogenicity and safety of a live attenuated varicella vaccine in children aged 1 to 12 years: A double-blind, randomized, parallel-controlled phase III clinical trial in China |
| title_full_unstemmed | Immunogenicity and safety of a live attenuated varicella vaccine in children aged 1 to 12 years: A double-blind, randomized, parallel-controlled phase III clinical trial in China |
| title_short | Immunogenicity and safety of a live attenuated varicella vaccine in children aged 1 to 12 years: A double-blind, randomized, parallel-controlled phase III clinical trial in China |
| title_sort | immunogenicity and safety of a live attenuated varicella vaccine in children aged 1 to 12 years a double blind randomized parallel controlled phase iii clinical trial in china |
| topic | Varicella vaccine chickenpox pediatric phase III immunogenicity safety |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2025.2452681 |
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