Efficacy, immunogenicity and safety of CoronaVac® in children and adolescents aged 6 months to 17 years: a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial

Qianqian Xin, Kaiqin Wang, Teck-Hock Toh, Yue Yuan, Xing Meng, Zhiwei Jiang, Hengming Zhang, Jinye Yang, Huijie Yang () and Gang Zeng ()
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Qianqian Xin: Sinovac Life Sciences Co., Ltd.
Kaiqin Wang: National Institutes for Food and Drug Control
Teck-Hock Toh: Sibu Hospital, Ministry of Health Malaysia
Yue Yuan: Sinovac Life Sciences Co., Ltd.
Xing Meng: Sinovac Biotech Co., Ltd.
Zhiwei Jiang: Beijing KEY TECH Statistical Technology Co., Ltd.
Hengming Zhang: Sinovac Biotech Co., Ltd.
Jinye Yang: Sinovac Life Sciences Co., Ltd.
Huijie Yang: National Institutes for Food and Drug Control
Gang Zeng: Sinovac Biotech Co., Ltd.

Nature Communications, 2024, vol. 15, issue 1, 1-10

Abstract: Abstract Safe and effective vaccines against COVID-19 for children and adolescents are needed. This international multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial assessed the efficacy, immunogenicity, and safety of CoronaVac® in children and adolescents (NCT04992260). The study was carried out in Chile, South Africa, Malaysia, and the Philippines. The enrollment ran from September 10, 2021 to March 25, 2022. For efficacy assessment, the median follow-up duration from 14 days after the second dose was 169 days. A total of 11,349 subjects were enrolled. Two 3-μg injections of CoronaVac® or placebo were given 28 days apart. The primary endpoint was the efficacy of the CoronaVac®. The secondary endpoints were the immunogenicity and safety. The vaccine efficacy was 21.02% (95% CI: 1.65, 36.67). The level of neutralizing antibody in the vaccine group was significantly higher than that in the placebo group (GMT: 390.80 vs. 62.20, P

Date: 2024
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DOI: 10.1038/s41467-024-50802-2

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