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drugset / Trial / NCT05216601

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901 or MVC-COV1901(Beta) Against COVID-19

NCT05216601 ↗

Phase 1 Completed 107 enrolled Medigen Vaccine Biologics Corp.
RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to assess the safety, tolerability, and immunogenicity of a 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 duration will be 1 day. -The visit frequency will be 6 on-site visits (1 screening visit, 1 treatment visit, and 4 follow- up visits) and 1 phone visit.

Timeline

Start
2022-05-06
Primary completion
2022-07-26
Completion
2022-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject MVC-COV1901 Vaccine 15 ug Intramuscular
Subject MVC-COV1901(Beta) Vaccine 15 ug Intramuscular
Subject MVC-COV1901(Beta) Vaccine 25 ug Intramuscular

Indications

No indication recorded.