NCT05398926

Immunogenicity and Safety of a Third Dose of COVID-19 Vaccine(Vero Cell), Inactivated in the Elderly

An Open Clinical Trial to Evaluate Immunogenicity and Safety of a Third Dose at Different Times After Two-dose of COVID-19 Vaccine (Vero Cell), Inactivated in the Elderly Aged 60 Years and Above

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Sinovac Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

This is an open phase Ⅲ clinical trial of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated in the Elderly Aged 60 years and above.

Detailed description

This study is an open phase Ⅲ clinical trial. The main purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research \& Development Co., Ltd. in the elderly aged 60 years and above.A total of 400 subjects aged 60 years and above who had received two doses of COVID-19 vaccine(Vero Cell), inactivated manufactured by Sinovac Research \& Development Co., Ltd. between 3 - 6 months ago (100 subjects for 3 months, 4 months, 5 months and 6 months,respectively) will be enrolled and receive a third dose of two-dose of COVID-19 vaccine (Vero cell), inactivated were enrolled.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 Vaccine (Vero cell), Inactivated	The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd.600SU inactivated SARS-CoV-2 CZ strain virus in 0.5 mL of aluminium hydroxide solution per injection.

Timeline

• Start date: 2021-12-06
• Primary completion: 2022-06-30
• Completion: 2022-07-30
• First posted: 2022-06-01
• Last updated: 2022-08-11

Locations

1 site across 1 country: China