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A Study to Evaluate the Safety and Immunogenicity of Booster With AZD1222, mRNA-1273, or MVC-COV1901 Against COVID-19

NCT05197153 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 804

Last updated 2023-03-15

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability, and immunogenicity of booster dose of vaccine in participants who are generally healthy or with stable pre-existing health conditions. Study details include:

* The study duration per participant will be approximately 209 days (28 days screening, 1 day vaccination, and 180 days follow-up).
* The treatment will include 1 booster dose only.
* The visit frequency will be 6 on-site visits and 1 phone visit.

Conditions

  • COVID-19 Vaccine

Interventions

BIOLOGICAL

Half dose of MVC-COV1901

Approximately 240 participants will receive 1 doses of half of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.

BIOLOGICAL

Full dose of MVC-COV1901

Approximately 240 participants will receive 1 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.

BIOLOGICAL

AZD1222

Approximately 240 participants will receive 1 doses of AZD1222 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.

BIOLOGICAL

Half dose of mRNA-1273

Approximately 240 participants will receive 1 doses half of mRNA-1273 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.

Sponsors & Collaborators

  • Coalition for Epidemic Preparedness Innovations

    collaborator OTHER

  • Medigen Vaccine Biologics Corp.

    lead INDUSTRY

Principal Investigators

  • Allen Lien, MD. DrPH · Medigen Vaccine Biologics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-01-22
Primary Completion
2022-06-01
Completion
2022-10-28

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 NCT05197153 on ClinicalTrials.gov