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

• Published in: Nature communications 2024-08, Vol.15 (1), p.6660-10, Article 6660
• Main Authors: Xin, Qianqian, Wang, Kaiqin, Toh, Teck-Hock, Yuan, Yue, Meng, Xing, Jiang, Zhiwei, Zhang, Hengming, Yang, Jinye, Yang, Huijie, Zeng, Gang
• Format: Article
• Language: English
• Subjects: 631/326/590/1883; 631/326/596/4130; 692/308/2779/109/1942; 692/308/2779/777; Adolescent; Adolescents; Antibodies, Neutralizing - blood; Antibodies, Neutralizing - immunology; Antibodies, Viral - immunology; Child; Child, Preschool; Children; Chile; Clinical trials; COVID-19; COVID-19 - immunology; COVID-19 - prevention & control; COVID-19 vaccines; COVID-19 Vaccines - administration & dosage; COVID-19 Vaccines - adverse effects; COVID-19 Vaccines - immunology; Double-Blind Method; Effectiveness; Female; Humanities and Social Sciences; Humans; Immunogenicity; Immunogenicity, Vaccine; Infant; Malaysia; Male; multidisciplinary; Philippines; Placebos; Safety; SARS-CoV-2 - immunology; Science; Science (multidisciplinary); Severe acute respiratory syndrome coronavirus 2; South Africa; Teenagers; Vaccine efficacy; Vaccines; Vaccines, Inactivated
• ISSN: 2041-1723; 2041-1723
• DOI: 10.1038/s41467-024-50802-2

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