NCT05077176

Phase 3 Booster Vaccination Against COVID-19

Open Label, Multi-Center Phase 3 Clinical Trial to Determine Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,340 (actual)
• Sponsor: Health Institutes of Turkey · Other Government
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The inactivated Booster Phase 3 study aims to determine the efficacy, safety, and immunogenicity of inactivated COVID-19 vaccines in subjects with a minimum of 90 days and a maximum of 270 days after the second dose of CoronaVac vaccine.

Detailed description

The inactivated Booster Phase 3 study aims to determine the efficacy, safety, and immunogenicity of inactivated COVID-19 vaccines in subjects with a minimum of 90 days and a maximum of 270 days after the second dose of CoronaVac vaccine. For the booster dose, subjects will be assigned open-label according to their preference for 2 different arms. The booster dose vaccine arms are as follows: * CoronaVac * Turkovac

Conditions

• COVID-19
• Sars-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	CoronaVac	One dose vaccine will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.
BIOLOGICAL	Turkovac	One dose vaccine will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.

Timeline

• Start date: 2021-10-08
• Primary completion: 2023-05-10
• Completion: 2024-02-05
• First posted: 2021-10-14
• Last updated: 2024-02-29

Locations

41 sites across 1 country: Turkey (Türkiye)