Observational Program, Study the Preventive Efficacy of the BiVac Polio Vaccine Against the Incid… (NCT05083039) | Clinical Trial Compass
CompletedNot Applicable
Observational Program, Study the Preventive Efficacy of the BiVac Polio Vaccine Against the Incidence of Acute Respiratory Infections, Including COVID-19
Russia1,500 participantsStarted 2020-05-14
Plain-language 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
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Volunteers must meet the following inclusion criteria:
* Healthy volunteers aged 18-65 years.
* The presence of a written and dated informed consent of the volunteer to participate in the program.
* Consent to observe precautionary measures to limit the circulation of the vaccine virus among people around the vaccinated person (personal hygiene, isolation from unvaccinated children and people with immunodeficiency).
* Volunteers who are able to fulfill the requirements of the protocol (i.e., fill out a self-observation diary, remember the dates of control visit).
Non-inclusion criteria:
* COVID-19 infection (including cases of asymptomatic carrier).
* Positive test for COVID-19 (PCR).
* Vaccination with any live and / or replicative vaccine one month before screening.
* Neurological disorders that accompany previous vaccination with oral polio vaccine.
* Immunodeficiency condition (primary).
* Malignant neoplasms.
* Immunosuppression (vaccinations are carried out no earlier than 3 months after the end of the course of therapy).
* Pregnancy.
* Hypersensitivity to any component of the vaccine.
* Strong reaction (temperature above 40°C) or a complication on the previous administration of the drug.
* Acute infectious or non-infectious diseases. Vaccinations are carried out 2-4 weeks after recovery or remission. In case of mild acute respiratory viral infections, acute intestinal diseases, vaccinations are carried out after the temperature normali…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of detected cases
Timeframe: within 12 months by groups
Trial details
NCT IDNCT05083039
SponsorChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products