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Observational Program, Study the Preventive Efficacy of the BiVac Polio Vaccine Against the Incidence of Acute Respiratory Infections, Including COVID-19

Coronavirus Infections Clinical Trial

Official title:
Observational Program to Study the Preventive Efficacy of the BiVac Polio (Oral Polio Vaccine, Divalent, Live Attenuated of Types 1 and 3 ) Vaccine Against the Incidence of Acute Respiratory Infections, Including COVID-19, Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", on Volunteers Aged 18-65

Clinical Trial Summary

Observational program, double-blind, placebo-controlled to study the preventive efficacy of the BiVac polio (Oral polio vaccine, divalent, live attenuated of types 1 and 3 vaccine against the incidence of acute respiratory infections, including COVID-19

Clinical Trial Description

To carry out a comparative assessment of the indices of humoral, cellular immunity and cytokine profile in patients with acute respiratory infections. Current Program Population: 1500 healthy male and female volunteers, aged of between 18 and 65 will be included in the program. All included volunteers will be divided into groups: Group 1 - 750 volunteers who will be vaccinated with BiVac polio vaccine; post-vaccination observation period of 12 months. Group 2 - 750 volunteers, placebo will be administered, post-vaccination observation period of 12 months. The probability of getting into one of the two groups for each volunteer will be 50%. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05083039
Study type Observational
Source Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
Contact
Status Completed
Phase
Start date May 14, 2020
Completion date September 3, 2021
View Details
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