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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of COVID-19 Vaccine, CT-COV-21 Extension Study

Covid19 Vaccine Clinical Trial

Official title:
A Phase II, Prospective, Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability, and Immunogenicity of the COVID-19 Vaccine Candidate MVC-COV1901, CT-COV-21 Extension Study

Clinical Trial Summary

The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine who are generally healthy or with stable pre-existing health conditions and have received 2 doses of Placebo in the main study CT-COV-21

Clinical Trial Description

This is an extension study of the main study CT-COV-21, "A Phase II, Prospective, Double-blinded, Multi-Center, Multi-Regional Study to Evaluate the Safety, Tolerability, and Immunogenicity of the SARS-CoV-2 Vaccine Candidate MVC-COV1901." This extension study is a prospective, open-label, multicenter study. In this extension study, approximately 500 participants who received the placebo and have remained blinded in the main study until Day 119 (90 days after the second vaccination of the main study) are enrolled and receive MVC-COV1901. Each participant will receive 2 doses of MVC-COV1901, administered 28 days apart via IM injection in the deltoid region, preferably of the non-dominant arm, at Day 1 and Day 29. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05048849
Study type Interventional
Source Medigen Vaccine Biologics Corp.
Contact
Status Completed
Phase Phase 2
Start date July 19, 2021
Completion date April 12, 2022
View Details
See also
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Active, not recruiting NCT04760704 - Covid-19 Vaccine Response in Elderly Subjects
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Recruiting NCT04834869 - COVID-19 Vaccines Safety Tracking (CoVaST)