NCT05165966

Safety and Immunogenicity Study of Booster Vaccination in Different Doses of COVID-19 Vaccine (Vero Cell),Inactivated for Prevention of COVID-19

A Randomized, Double-Blinded Clinical Trial to Evaluate the Immunogenicity Using Additional Dose of Medium-dosage or High-dosage COVID-19 Vaccine (Vero Cell), Inactivated in Populations Who Have Completed Primary Immunization 5-9 Months

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Sinovac Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Life Sciences Co. , Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months

Detailed description

This study a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated.The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months.A total of 340 subjects who have completed primary immunization using two-dose Coronavac® 5-9 months were be enrolled.All of subjects were be randomly divided into two groups in a 1:1 ratio to receive high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	High-dosage of COVID-19 vaccine (Vero cell), Inactivated	High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection
BIOLOGICAL	Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated	Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated: 600SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection

Timeline

• Start date: 2021-10-20
• Primary completion: 2022-04-20
• Completion: 2022-07-01
• First posted: 2021-12-21
• Last updated: 2022-08-11

Locations

1 site across 1 country: China