Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Coronavirus Infection
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Open prospective non-randomized studyMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 60 years and 111 years
Gender
Both males and females

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 ...

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

Tracking Information

NCT #
NCT04587219
Collaborators
Not Provided
Investigators
Principal Investigator: Nikita Lomakin, MD, PhD Federal state budgetary institution "Central clinical hospital with polyclinic" Of the office Of the President of the Russian Federation