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

  • STATUS
    Not Recruiting
  • days left to enroll
    83
  • participants needed
    960
  • sponsor
    Medigen Vaccine Biologics Corp.
Updated on 14 September 2022
Accepts healthy volunteers

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.

Description

This is a Phase II, prospective, randomized, observer-blinded, multi-center study, to evaluate the safety, tolerability, and immunogenicity of a booster vaccination with AZD1222, mRNA-1273, or MVC-COV1901 vaccine. Approximately 960 participants aged 18 ~ < 80 years, who received homologous two doses of vaccines 150 ~ 365 days ago, will be enrolled and divided into three groups. Each group will consist of 320 eligible subjects, and for each group the randomization will be stratified according to study site and age to four treatments (AZD1222, half dose of mRNA-1273, full dose or half dose of MVC-COV1901 in 1:1:1:1 ratio). Therefore, within a group, for either age stratum, there will be at least 30 participants for each treatment.

Details
Condition COVID-19 Vaccine
Treatment AZD1222, Half dose of MVC-COV1901, Full dose of MVC-COV1901, Half dose of mRNA-1273
Clinical Study IdentifierNCT05197153
SponsorMedigen Vaccine Biologics Corp.
Last Modified on14 September 2022

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