The Study of "Gam-COVID-Vac" Vaccine Against COVID-19 With the Participation of Volunteers of 60 y.o and Older
Last updated on July 2021Recruitment
- 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