NCT04884685

Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Children and Adolescents

A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱb Clinical Trial, to Evaluate the Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 3 to 17 Years.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Sinovac Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, double-blinded, placebo-controlled, phase Ⅱb clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Life Sciences Co. , Ltd.The purpose of this study is to evaluate the safety of the SARS-CoV-2 Inactivated vaccine in healthy children and adolescents aged 3-17 years.

Detailed description

This study is a randomized, double-blinded, placebo-controlled,phase Ⅱb clinical trial in children and adolescents aged 3-17 years. The experimental vaccine and placebo were both manufactured by Sinovac Life Sciences Co. , Ltd. A total of 500 subjects will be enrolled, including 100 children aged 3-5 years, 200 children aged 6-11 years and 200 adolescents aged 12-17 years. Each age group will be randomly divided into two groups in a 3:1 ratio and received two doses of experimental vaccine or placebo on on day 0 and day 28.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 Inactivated Vaccine	600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
BIOLOGICAL	Placebo	aluminium hydroxide solution only

Timeline

• Start date: 2021-05-03
• Primary completion: 2021-08-01
• Completion: 2022-06-20
• First posted: 2021-05-13
• Last updated: 2023-09-22

Locations

1 site across 1 country: China