Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT05038618
Status:
COMPLETED
Last Update Posted:
2022-06-13
First Post:
2021-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study o Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901, CT-COV-21 Sub-study
Sponsor:
Medigen Vaccine Biologics Corp.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: