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The Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac

Influenza A Clinical Trial

Official title:
An Open Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac Vector Vaccine Against Influenza A in Healthy Volunteers in 3 Groups With a Dose Escalation

Clinical Trial Summary

The present clinical phase I study designed to examine the safety, reactogenicity and immunogenicity of the medicinal product - Vaccine vector against influenza A - in healthy volunteers after a single dose in the three groups with dose escalation.

Clinical Trial Description

According to the results of the screening of volunteers who signed the informed consent Form, a sequential set of three groups of volunteers with different doses of the drug, the total number of volunteers who received the drug will be at least 36 people.

Given the fact that the drug is investigated for the first time with the participation of the people, will initially be admitted to hospital on 5 volunteers who will receive the investigational drug in the 1 dose The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) x 10*10 VP/dose). If the safety of the drug is confirmed by the results of observation on the 7th day of the study, the study will continue with the participation of 7 more volunteers in this dosing group.

Further, according to a similar scheme (each time after an interim safety assessment on day 7), the study will include volunteers receiving the drug at a dose of 0.5 ml (Total amount of recombinant pseudo-adenoviral particles (1.0 ± 0.5) x 1011 VP/dose), particles/dose and 0.5 ml, -The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose . ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03651544
Study type Interventional
Source Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Contact
Status Completed
Phase Phase 1
Start date October 15, 2018
Completion date March 14, 2019
View Details
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