NCT05433272

Immunogenicity and Safety Study of One Booster Dose of Trivalent COVID-19 Vaccine (Vero Cell), Inactivated

A Randomized, Double-Blind, Active-controlled Phase Ⅲ Clinical Trial to Evaluate the Immunogenicity and Safety of One Booster Dose of Trivalent COVID-19 Vaccine (Vero Cell), Inactivated in Healthy People in Colombia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,400 (estimated)
• Sponsor: Sinovac Biotech (Colombia) S.A.S. · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, active-controlled phase Ⅲ clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of one booster dose of trivalent COVID-19 vaccine (vero cell), inactivated, prototype strain, delta strain and omicron strain in healthy people aged 3 years old and above and have completed two or three doses of CoronaVac® in Colombia.

Detailed description

This is a randomized, double-blind, and active-controlled Phase Ⅲ bridging clinical trial of 1,400 subjects aged 3 years and above and have completed two or three doses of CoronaVac at least 3 months prior to this study.After enrollment, subjects will be randomly assigned into 2 groups at a ratio of 1:1 to receive one dose of trivalent COVID-19 vaccine or CoronaVac®.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron Strain	The Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron Strain was developed by Sinovac Life Science Ltd. The antigen content of trivalent COVID-19 vaccine is a total of 18μg/0.5 ml, including 1200 SU/6 µg/0.5 ml for Prototype strain, 1200 SDU/6 µg/0.5 ml for Delta strain, and 1200 SOU/6 µg/0.5 ml for Omicron strain. The routine of administration is Intramuscular injection into deltoid region.
BIOLOGICAL	COVID-19 Vaccine (Vero Cell), Inactivated	The COVID-19 Vaccine (Vero Cell),Inactivated was manufactured by Sinovac Life Science Ltd.The antigen content of the active-controlled vaccine (CoronaVac) is 600 SU/3 µg/0.5 ml.The routine of administration is Intramuscular injection into deltoid region.

Timeline

• Start date: 2023-08-10
• Primary completion: 2023-09-10
• Completion: 2023-09-10
• First posted: 2022-06-27
• Last updated: 2023-01-12

Locations

1 site across 1 country: Colombia