NCT05083039

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (actual)
• Sponsor: Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed 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%.

Conditions

• Coronavirus Infections
• Vaccine
• Polio

Timeline

• Start date: 2020-05-14
• Primary completion: 2020-12-14
• Completion: 2021-09-03
• First posted: 2021-10-19
• Last updated: 2023-02-08

Locations

1 site across 1 country: Russia