Efficacy, Immunogenicity and Safety of COVID-19 Vaccine , Inactivated in Children and Adolescents

Summary

This study is a global multi-center , case-driven, randomized, double-blinded, and placebo-controlled phase Ⅲ clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the efficacy of two dose of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 6 months to 17 years.

Timeline

Start

2021-09-10

Primary completion

2023-05-31

Completion

2023-05-31

Publications

• Xin Q, Wang K, Toh TH, Yuan Y, Meng X, Jiang Z, Zhang H, Yang J, Yang H, Zeng G. Efficacy, immunogenicity and safety of CoronaVac(R) in children and adolescents aged 6 months to 17 years: a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. Nat Commun. 2024 Aug 6;15(1):6660. doi: 10.1038/s41467-024-50802-2.
• Rivera-Perez D, Mendez C, Diethelm-Varela B, Melo-Gonzalez F, Vazquez Y, Meng X, Xin Q, Fasce RA, Fernandez J, Mora J, Ramirez E, Acevedo ML, Valiente-Echeverria F, Soto-Rifo R, Grifoni A, Weiskopf D, Sette A, Astudillo P, Le Corre N, Abarca K, Perret C, Gonzalez PA, Soto JA, Bueno SM, Kalergis AM. Immune responses during COVID-19 breakthrough cases in vaccinated children and adolescents. Front Immunol. 2024 May 15;15:1372193. doi: 10.3389/fimmu.2024.1372193. eCollection 2024.
• Soto JA, Melo-Gonzalez F, Gutierrez-Vera C, Schultz BM, Berrios-Rojas RV, Rivera-Perez D, Pina-Iturbe A, Hoppe-Elsholz G, Duarte LF, Vazquez Y, Moreno-Tapia D, Rios M, Palacios PA, Garcia-Betancourt R, Santibanez A, Pacheco GA, Mendez C, Andrade CA, Silva PH, Diethelm-Varela B, Astudillo P, Calvo M, Cardenas A, Gonzalez M, Goldsack M, Gutierrez V, Potin M, Schilling A, Tapia LI, Twele L, Villena R, Grifoni A, Sette A, Weiskopf D, Fasce RA, Fernandez J, Mora J, Ramirez E, Gaete-Argel A, Acevedo ML, Valiente-Echeverria F, Soto-Rifo R, Retamal-Diaz A, Munoz-Jofre N; PedCoronaVac03CL Study Group,; Meng X, Xin Q, Alarcon-Bustamante E, Gonzalez-Aramundiz JV, Le Corre N, Alvarez-Figueroa MJ, Gonzalez PA, Abarca K, Perret C, Carreno LJ, Bueno SM, Kalergis AM. Inactivated Vaccine-Induced SARS-CoV-2 Variant-Specific Immunity in Children. mBio. 2022 Dec 20;13(6):e0131122. doi: 10.1128/mbio.01311-22. Epub 2022 Nov 16.

Drugs

Indications