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Clinical Trial Summary

A Randomized, Double Blind, Positive Control Clinical Study to Evaluate the Immunogenicity and Safety of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines


Clinical Trial Description

This is a Randomized, Double Blind, Positive Control exploratory clinical study. 150 participants aged 18 years and older who have completed the 2 doses of administration of inactive vaccines 6 months (±1 month) ago were enrolled in this study to evaluate the safety and immunogenicity of V-01. The participants will be enrolled to test group A (V-01 10 μg), test group B (V-01 25 μg) and test group C (inactivated vaccine) by the ratio of 1:1:1. The participants received 1 dose of V-01 or inactivated vaccine base on the group. The random stratification factor is age (18-59 years old vs. ≥ 60 years old). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05238649
Study type Interventional
Source Livzon Pharmaceutical Group Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 10, 2021
Completion date January 28, 2023

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