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Study of the EpiVacCorona Vaccine With the Involvement of Volunteers Aged 60 Years and Above

Covid19 Clinical Trial

Official title:
An Open Study of the Safety, Reactogenicity and Immunogenicity of the Vaccine Based on Peptide Antigens for the Prevention of COVID-19 (EpiVacCorona), With the Involvement of Volunteers Aged 60 Years and Above (Phase III-IV)

Clinical Trial Summary

The aim of the clinical study is to study the safety, reactogenicity and immunogenicity indicators of the EpiVacCorona vaccine, with the involvement of volunteers aged 60 years and above. The research tasks are to: - to evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly, with the participation of volunteers aged 60 years and older; - to evaluate the reactogenicity of the EpiVacCorona vaccine when administered twice intramuscularly, with the participation of volunteers aged 60 years and older; - to identify any adverse effects to the administration of the vaccine; - to study the humoral and cellular immune responses response following two doses of the EpiVacCorona vaccine, with the participation of volunteers aged 60 and older.

Clinical Trial Description

The study will screen a maximum of 180 volunteers, of which it is proposed to include and randomize 150 men and women aged 60 years and older who meet the inclusion criteria and who do not have the exclusion criteria whose data will be used for subsequent safety and immunogenicity analysis. The 150 volunteers will be vaccinated with the EpiVacCorona vaccine with two doses spaced 21 days apart, intramuscularly, at a dose of 0.5 ml. The vaccine will be administered in procedure room settings only by a highly qualified specialist (vaccinator). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05021016
Study type Interventional
Source Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"
Contact
Status Completed
Phase Phase 3
Start date November 19, 2020
Completion date January 30, 2021
View Details
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