NCT04695652

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3,854 (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 compared to placebo in participants who are generally healthy or with stable pre-existing health conditions.

Detailed description

This is a Phase II, prospective, placebo-controlled, double-blinded (investigator/site staff and participants), multi-center, multi-regional study; the Sponsor will be blinded until the interim analysis. Participants who are generally healthy or with stable pre-existing health conditions will be randomized, stratified by age (≥ 20 to \< 65 years and ≥ 65 years of age).All eligible participants will be randomized to receive 2 doses of either MVC-COV1901 or placebo in a predefined ratio.

Conditions

• Covid19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	MVC-COV1901(S protein with adjuvant)	Approximately 3180 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(Saline)	Approximately 530 participants will receive 2 doses of MVC-COV1901(Saline) at Visit 2 (Day 1) and Visit 4 (Day 29) via IM injection in the deltoid region

Timeline

• Start date: 2020-12-30
• Primary completion: 2021-05-15
• Completion: 2021-10-29
• First posted: 2021-01-05
• Last updated: 2022-01-31

Locations

12 sites across 2 countries: Taiwan, Vietnam