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Clinical Trial Summary

This study is a randomized, double-blinded, and placebo-controlled phase Ib/IIb clinical trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the vaccine in healthy people aged ⩾60 Years.


Clinical Trial Description

This phase Ib/IIb trial is designed to evaluate the safety and immunogenicity of different doses of the Inactivated SARS-CoV-2 Vaccine based upon the randomized, double-blind and placebo-controlled principle. A total of 471 subjects aged ⩾60 years will be enrolled in the study, of which 96 and 375 will be enrolled for phase Ib and phase Ⅱb,respectively. The enrolled subjects in phase Ib receive two doses of low-, medium-, or high-dose of experimental vaccines or placebo at an interval of 28 days, while the enrolled subjects in Phase Ⅱb receive two doses of medium, high-dose experimental vaccines or placebo at an interval of 28 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04470609
Study type Interventional
Source Institute of Medical Biology, Chinese Academy of Medical Sciences
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 10, 2020
Completion date October 27, 2021

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