Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Severity of local reactions reported by participants of the study and their relationship with the vaccination
研究概览
简要总结
Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years
详细描述
All subjects will be followed up for 21 days post-randomization. The subjects will further be assessed at 2 days, 7 days, 21 days following the booster vaccination. Blood samples will be collected for reactogenicity and safety and immunogenicity assessments before injection and 21 days after vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent of the volunteers to participate in the clinical study;
- •Healthy volunteers (men and women) aged 18-60 years;
- •Volunteers with a titer of antibodies to A(H1N1), A(H3N2) and B influenza viruses less than 1:40 in a HI test
- •Volunteers able to fulfill requirements of the protocol (i.e. fill out the patient's diary, come to follow-up visits);
- •Female participants were obliged to have negative pregnancy test results and use contraceptives throughout the follow-up period (complete contraception for women of reproductive age)
排除标准
- •Allergic reactions to chicken protein or any previous influenza vaccination;
- •Leukemia, cancer or a positive reaction to HIV infection, hepatitis B and C, syphilis in the medical history;
- •Volunteers who received immunoglobulin or blood products within the last three months before the study;
- •Guillain-Barre syndrome (acute polyneuropathy) in the medical history;
- •Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for six months before the study;
- •Any confirmed or suspected immunosuppressive or immunodeficiency condition;
- •Respiratory, cardiovascular failure, impaired liver or kidney function found during a physical examination or laboratory tests at Visit 1;
- •Severe birth defects or serious chronic diseases, including any clinically significant chronic diseases of lungs, kidneys, cardiovascular, nervous system, psychiatric diseases or metabolic disorders, confirmed by medical history or objective examination;
- •Volunteers who are (or were) patients of a tuberculosis dispensary and/or narcological dispensary and/or neuropsychiatric dispensary
- •acute infectious and/or non-infectious diseases at the time of inclusion in the study;
- •Exacerbation of chronic diseases;
- •Alcohol abuse and/or use of drugs in the past history;
- •Pregnancy and lactation;
- •Participation in another clinical study within the last 3 months
结局指标
主要结局
Severity of local reactions reported by participants of the study and their relationship with the vaccination
时间窗: days 8-20
Severity of reported local reactions and their relationship with the vaccination
时间窗: days 1-7
Severity of reported system reactions and their relationship with the vaccination - during 7 days after the vaccination (the day of vaccination and 6 subsequent days)
时间窗: days 1-7
Severity of system reactions reported by participants of the study and their relationship with the vaccination
时间窗: days 8-20
The measurement physical data at each visit of the trial site by the volunteer
时间窗: days 1-20
次要结局
- The immunogenicity assessment of the vaccine was carried out by seroconversion(Measurements will be taken at screening, then up to 21 days post-vaccination)
- The immunogenicity assessment of the vaccine was carried out by the seroconversion factor(Measurements will be taken at screening, then up to 21 days post-vaccination)
- The immunogenicity assessment of the vaccine was carried out by Geometric mean titer(Measurements will be taken at screening, then up to 21 days post-vaccination)
- The immunogenicity assessment of the vaccine was carried out by seroprotection levels(Measurements will be taken at screening, then up to 21 days post-vaccination)