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

NCT05038618 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2022-06-13

No results posted yet for this study

Summary

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

Conditions

  • Covid19 Vaccine

Interventions

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

Sponsors & Collaborators

  • Medigen Vaccine Biologics Corp.

    lead INDUSTRY

Principal Investigators

  • Szu-Min Hsieh, MD · National Taiwan University Hospital

  • Tzou-Yien Lin, MD · Chang Gang Memorial Hospital, LinKou

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-02
Primary Completion
2021-10-14
Completion
2022-03-11

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05038618 on ClinicalTrials.gov