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

NCT04951388 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2022-04-20

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine compared to placebo in participants aged ≥ 12 to \< 18 years.

Conditions

  • Covid19 Vaccine

Interventions

BIOLOGICAL

MVC-COV1901(S protein with adjuvant)

Approximately 330 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 55 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

Sponsors & Collaborators

  • Medigen Vaccine Biologics Corp.

    lead INDUSTRY

Principal Investigators

  • Li-Min Huang, M.D., Ph.D. · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-22
Primary Completion
2021-10-25
Completion
2022-03-21

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 NCT04951388 on ClinicalTrials.gov