NCT04962308

Clinical Trial of Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults

An Open-label,Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 18 to 59 Years.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,400 (estimated)
• Sponsor: Sinovac Research and Development Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This study is an open-label phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 18 to 59 Years.

Detailed description

This study is an open-label phase Ⅳ clinical trial in healthy adult aged 18-59 years. The experimental vaccine was manufactured by Sinovac Research and Development Co.,Ltd.. A total of 1400 subjects will be enrolled,the safety and immunogenicity of booster immunization were evaluated in 400 subjects (group A) who received two doses of primary immunization at an interval of 21 to 31 days. And the safety of booster immunization was evaluated in the extended safety group (group B), which included 1000 subjects.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 Inactivated Vaccine	600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
BIOLOGICAL	The SARS-CoV-2 Inactivated Vaccine	600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection

Timeline

• Start date: 2021-06-19
• Primary completion: 2021-08-19
• Completion: 2021-12-19
• First posted: 2021-07-14
• Last updated: 2021-09-24

Locations

1 site across 1 country: China