NCT05038618

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 399 (actual)
• Sponsor: Medigen Vaccine Biologics Corp. · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Covid19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	MVC-COV1901(S protein with adjuvant)	Approximately 400 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: 2021-08-02
• Primary completion: 2021-10-14
• Completion: 2022-03-11
• First posted: 2021-09-09
• Last updated: 2022-06-13

Locations

1 site across 1 country: Taiwan