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The Study of "Gam-COVID-Vac" Vaccine Against COVID-19 With the Participation of Volunteers of 60 y.o and Older

Coronavirus Infection Clinical Trial

Official title:
An Open Study of the Safety, Tolerability and Immunogenicity of the "Gam-COVID-Vac"Vaccine Against COVID-19 (Solution for Intramuscular Injection) With the Participation of Volunteers in the Age Group Over 60 Years

Clinical Trial Summary

The purpose of this study: to assess the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac", a solution for intramuscular injection, at various times after vaccination in volunteers over 60 years of age

Clinical Trial Description

An open-ended prospective non-randomized study involving volunteers over the age of 60. The study will include 110 volunteers. who will receive the test drug according to the prime-boost scheme: the introduction of component 1 will be carried out on the 1st day, and component 2 - on the 21st day of the study. Outpatient monitoring will be performed during 4 visits: on the 7th, 14th, 28th, and 42nd days after the vaccine administration Also two visits will be performed in the phone contact mode for 90 and 180 days ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04587219
Study type Interventional
Source Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Contact
Status Active, not recruiting
Phase Phase 2
Start date October 22, 2020
Completion date April 30, 2021
View Details
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