NCT04756830

A Study to Assess the Safety and Immunogenicity of the Coronavac Vaccine Against COVID-19

An Open-label Uncontrolled Study to Assess the Safety and Immunogenicity of the Inactivated Adsorbed Vaccine Against COVID-19 (Coronavac) in Individuals Over 18 Years of Age During 24 Months of Follow-up

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: D'Or Institute for Research and Education · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is an open-label uncontrolled study in which all participants will receive two doses of the inactivated adsorbed vaccine against COVID-19, and will be followed up for safety and immunogenicity analysis for 24 months.

Detailed description

This is an open-label uncontrolled study in which all participants will receive two doses of the inactivated adsorbed vaccine against COVID-19, and will be followed up for safety and immunogenicity analysis for 24 months. This study will assess safety and immunogenicity of the inactivated vaccine adsorbed against COVID-19 (CoronaVac) in a population of healthy individuals older than 18 years of age. The estimated number of participants is 1200. Participants will be recruited within 3-4 months. The total duration of the study is estimated to be 30 months after recruitment begins. The participants will remain in the study for approximately 24 months. The study will be carried out at the clinical research center of the D'Or Institute for Research and Education (IDOR) located at the Hospital Glória D'Or, in the city of Rio de Janeiro, RJ, Brazil

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Adsorbed COVID-19 (inactivated) Vaccine	Participants will receive two doses with 14-days interval of adsorbed COVID-19 (inactivated) vaccine

Timeline

• Start date: 2021-02-19
• Primary completion: 2021-09-01
• Completion: 2023-06-01
• First posted: 2021-02-16
• Last updated: 2021-07-09

Locations

2 sites across 1 country: Brazil