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Phase I Clinical Trial of COVID-19 mRNA Vaccine in Adults Aged 18 Years and Older

COVID-19 Clinical Trial

Official title:
A Randomized, Double-blind, Dose-exploring, Placebo-controlled, Multi-center Phase I Clinical Trial Evaluating the Safety and Immunogenicity of COVID-19 mRNA Vaccine in Adults Aged 18 Years and Older

Clinical Trial Summary

To evaluate the safety and immunogenicity of the COVID-19 mRNA vaccine in people aged 18 years and older, 80 participants will be enrolled and divided into two groups: low- and high-dose groups. Each dose group will be divided into 2 age groups (20 people each):18 to 59 years old and ≥ 60 years old. Subjects will be randomized into vaccine group or placebo group in a ratio of 3:1. Subjects will receive 2 doses of either vaccine or placebo on Day 0 and Day 21, in which the low-dose group will received 0.3 ml of the study vaccine or placebo, and the high dose group will receive 0.5 ml of the study vaccine or placebo.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05373485
Study type Interventional
Source CanSino Biologics Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date May 20, 2022
Completion date December 20, 2023
View Details
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