NCT05048849

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Medigen Vaccine Biologics Corp. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Covid19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	MVC-COV1901(S protein with adjuvant)	Approximately 500 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region

Timeline

• Start date: 2021-07-19
• Primary completion: 2021-11-08
• Completion: 2022-04-12
• First posted: 2021-09-17
• Last updated: 2022-08-24

Locations

11 sites across 1 country: Taiwan