Clinical Trials Logo
  1. Home
  2. Covid19
  3. NCT05038618

A Study o Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901, CT-COV-21 Sub-study

Covid19 Vaccine Clinical Trial

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

Clinical Trial Summary

This sub-study is a prospective open-label, single-center study to demonstrate comparability of different manufacturing scales.

Clinical Trial Description

In this sub-study, approximately 400 adults participants who are generally healthy or with stable pre-existing health conditions aged ≥ 20 to < 65 years will be enrolled. The first 250 participants enrolled in this sub-study will receive MVC-COV1901(Scale A) and the remains will receive MVC-COV1901(Scale B). Each participant will receive 2 doses of study intervention, administered 28 days apart via IM injection in the deltoid region, preferably of the nondominant arm, at Day 1 and Day 29. The study procedure and visit schedule refer to the main study protocol and will be the same as the study procedure for the Immunogenicity Subset. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05038618
Study type Interventional
Source Medigen Vaccine Biologics Corp.
Contact
Status Completed
Phase Phase 2
Start date August 2, 2021
Completion date March 11, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT05079633 - A Heterologous Prime-boost Study to Evaluate Immunogenicity and Safety of mRNA-1273 With MVC-COV1901 in Adults Phase 4
Completed NCT05011526 - A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 Against COVID-19 in Adults Phase 3
Completed NCT04822025 - A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Elderly Adults Phase 2
Completed NCT04818892 - Immunogenicity of COVID-19 Vaccine in Patients With Inflammatory Bowel Disease
Completed NCT04951388 - A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adolescents Phase 2
Not yet recruiting NCT04730895 - Investigating the Role of 13cis Retinoic Acid in the Treatment of COVID-19 and Enhancement of Its Spike Protein Based Vaccine Efficacy and Safety. Phase 1/Phase 2
Completed NCT05048849 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of COVID-19 Vaccine, CT-COV-21 Extension Study Phase 2
Completed NCT04765436 - PTX-COVID19-B, an mRNA Humoral Vaccine, is Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Evaluate Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Vaccine in Healthy Seronegative Adults Aged 18-64 Phase 1
Active, not recruiting NCT04760704 - Covid-19 Vaccine Response in Elderly Subjects
Completed NCT04695652 - A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adult Phase 2
Withdrawn NCT05029245 - IntraDermal Versus Intramuscular Comirnaty® Efficacy Study Phase 3
Completed NCT05175742 - PTX-COVID19-B, an mRNA Humoral Vaccine, Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Demonstrate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B in Comparison to the Pfizer-BioNTech COVID-19 Vaccine. Phase 2
Recruiting NCT04834869 - COVID-19 Vaccines Safety Tracking (CoVaST)