NCT05198336

Immunogenicity of an Inactivated COVID-19 Vaccine

Immunogenicity of an Inactivated COVID-19 Vaccine for Prevention of COVID-19 in Population Aged 3-11 Years

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 395 (actual)
• Sponsor: Sinovac Research and Development Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Accepted

Summary

This study is an open phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity of the CoronaVac in healthy children aged 3-11 years old.

Detailed description

This study is an open phase 4 clinical trial to evaluate the immunogenicity of an inactivated COVID-19 vaccine(CoronaVac)in healthy children aged 3-11 years old.A total of 400 healthy subjects who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd and is currently 28-42 days after the second dose will be enrolled, including 200 subjects aged 3-5 years and 200 subjects aged 6-11 years old.All of subjects will be collected 3ml venous blood to evaluate the immunogenicity of the CoronaVac.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated COVID-19 Vaccine	600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

Timeline

• Start date: 2022-01-08
• Primary completion: 2022-01-24
• Completion: 2022-12-30
• First posted: 2022-01-20
• Last updated: 2023-09-25

Locations

1 site across 1 country: China