NCT05254236

Immunogenicity and Safety Study of the 3rd Booster Dose Using the High or Medium Dose of Inactivated Vaccine in Healthy Adults in in Hong Kong

A Phase IIb, Randomized, Double-Blinded Trial to Evaluate the Immunogenicity and Safety Study of the Booster Dose Using the High or Medium Dose of COVID- 19 Vaccine (Vero Cell), Inactivated in Healthy Adults Who Have Completed Two Doses of mRNA Vaccine in Hong Kong

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sinovac Research and Development Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blinded, Phase IIb clinical trial of COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate to evaluate the changes in immunogenicity before and after the booster vaccine using the high (1200 SU) or medium (600 SU) dose of COVID-19 Vaccine (Vero Cell), Inactivated.

Detailed description

This is a randomized, double-blinded, Phase IIb clinical trial of 150 participants aged 18 years and above, who have completed two doses of mRNA COVID-19 vaccine as the primary vaccination for at least six months after the second dose. After enrollment, participants will be randomly assigned into two study arms at a ratio of 1:1 to receive a booster of one dose of medium-dose (600 SU) or one dose of high-dose (1200 SU) COVID-19 Vaccine.

Conditions

• COVID-19

Interventions

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

Timeline

• Start date: 2022-02-10
• Primary completion: 2022-03-10
• Completion: 2022-03-10
• First posted: 2022-02-24
• Last updated: 2023-09-22

Locations

1 site across 1 country: China