NCT04822025

A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Elderly Adults

A Phase II, Prospective, Randomized, Double-Blind, Dose-Comparison, Multi-Center Study to Evaluate the Safety, Tolerability, and Immunogenicity of the SARS-CoV-2 Vaccine Candidate MVC-COV1901 in Elderly Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Medigen Vaccine Biologics Corp. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine in two different dose forms in participants who are generally healthy or with stable pre-existing health conditions.

Detailed description

This is a Phase II, prospective, randomized, double-blinded (investigator/site staff and participants; Sponsor open), dose-comparison, multi-center study. Participants who are generally healthy or with stable pre-existing health conditions will be randomized, stratified by comorbidity. All eligible participants will be randomized to receive 2 doses of either High-dose or Mid-dose of MVC-COV190 in a predefined ratio.

Conditions

• Covid19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	MVC-COV1901 (High-Dose)	Approximately 300 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region
BIOLOGICAL	MVC-COV1901(Mid-Dose)	Approximately 100 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region

Timeline

• Start date: 2021-05-20
• Primary completion: 2021-08-25
• Completion: 2022-01-28
• First posted: 2021-03-30
• Last updated: 2022-06-28

Locations

4 sites across 1 country: Taiwan