NCT05083039已完成不适用
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
Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2020年5月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- The number of detected cases
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 normalizes.
- •The presence in the family or immediate environment (and provided that it is impossible to separate) of unvaccinated against polio (for example, newborns or children who have contraindications to polio vaccinations).
- •The presence of persons with immunodeficiency in the family or immediate environment (and provided that it is impossible to separate).
排除标准
- •A volunteer can be excluded from the study under the following conditions:
- •Refusal of a volunteer to participate in the program.
- •The need for procedures and / or drug treatment that are not permitted by the protocol of this study.
- •The volunteer was included in violation of the inclusion/non-inclusion criteria of the Protocol.
- •The appearance of non-inclusion criteria during the study.
- •Non-compliance with the research procedures by the volunteer.
- •Any condition of the volunteer that requires, in the reasonable opinion of the research doctor, the withdrawal of the volunteer from the study.
- •The volunteer is out of observation. • For administrative reasons
结局指标
主要结局
The number of detected cases
时间窗: within 12 months by groups
The number of detected cases confirmed by laboratory (PCR and / or serological tests).
次要结局
未报告次要终点
研究者
研究点 (1)
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