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 range18 Years – 65 Years
SexALL
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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…
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