Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA vs. the Vaxigrip® Inactivated Influenza Split Vaccine Manufactured by Sanofi Pasteur, France, in Volunteers Aged 18-60 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Results of assessment of heart rate (HR)
研究概览
简要总结
To trial the reactogenicity, safety and immunogenicity of the 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
- Double (Participant, Investigator)
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 trial;
- •Healthy volunteers (men and women) aged 18-60 years;
- •Volunteers able to fulfill requirements of the protocol (fill out the patient's diary, come to follow-up visits);
- •If the participant is female, she was required to have negative pregnancy test results and use contraceptives throughout the follow-up period (complete contraception of women of reproductive period)
排除标准
- •Allergic reactions to chicken protein or any previous influenza vaccination;
- •Leukemia, cancer or a positive reaction to human immunodeficiency virus infection, hepatitis B and C, syphilis in the past medical history;
- •Volunteers who received immunoglobulin or blood products within the last 3 months before the trial;
- •Guillain-Barré syndrome (acute polyneuropathy) in the medical history;
- •Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for 6 months prior to the trial.
- •Any confirmed or suspected immunosuppressive or immunodeficiency condition;
- •Respiratory, cardiovascular failure, impaired liver or kidney function found during a physical examination or laboratory tests during 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;
- •Being (or having been) a patient 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 trial;
- •Exacerbation of chronic diseases;
- •chronic alcohol abuse and/or use of drugs in the past history;
- •Pregnancy and lactation;
- •Participation in another clinical trial within the last 3 months;
- •Immunization with influenza vaccines in the last 6 months
结局指标
主要结局
Results of assessment of heart rate (HR)
时间窗: days 1-21 post-vaccination
The measurement of HR at each visit of the trial site by the volunteer
Incidence of AEs associated with the vaccination
时间窗: days 1-21 post-vaccination
Incidence of SAEs associated with the vaccination
时间窗: days 1-21 post-vaccination
Results of assessment of systolic and diastolic blood pressure (BP)
时间窗: days 1-21 post-vaccination
The measurement of systolic and diastolic BP at each visit of the trial site by the volunteer
Results of biochemical blood tests
时间窗: days 3, 7 and 21
* ALT (U/L) * AST (U/L) * Alkaline phosphatase (U/L)
Results of complete blood counts
时间窗: days 3, 7 and 21
Erythrocytes (10\^12/L)
Severity of observed local reactions and their relationship with the vaccination
时间窗: days 1-21 post-vaccination
% of patients with: • Pain at the injection site at pressing Measurement tool: 4-point scale: 0 - none, 1 - mild, 2 - moderate, 3 - severe. Unit of measure: % of symptomatic patients at each severity
Severity of observed system reactions and their relationship with the vaccination
时间窗: days 1-21 post-vaccination
% of patients with: • Fever Measurement tool: 4-point scale: 0 - none (≤ 37°С), 1 - mild (\> 37°С - ≤ 37.5°С), 2 - moderate (\> 37.6°С - ≤ 38.5°С), 3 - severe (\> 38.6°С). Unit of measure: % of symptomatic patients at each severity
次要结局
未报告次要终点