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An Open Study of the Safety, Tolerability and Immunogenicity of "Gam-COVID-Vac Lyo" Vaccine Against COVID-19

NCT04437875 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-08-12

No results posted yet for this study

Summary

the purpose of this study: to evaluate the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac Lyo", a lyofilizate for preparing solution for intramuscular administration, at various times after vaccination in healthy adult volunteers.

Conditions

  • Preventive Immunization COVID-19

Interventions

BIOLOGICAL

Gam-COVID-Vac Lyo

adenoviral-based vaccine against SARS-CoV-2

Sponsors & Collaborators

  • Acellena Contract Drug Research and Development

    collaborator OTHER

  • Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

    lead OTHER

Principal Investigators

  • Lola Morozova, Md · I.M. Sechenov First Moscow State Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-17
Primary Completion
2020-08-03
Completion
2020-08-10

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04437875 on ClinicalTrials.gov