NCT05312294已完成3 期
Multicenter, Double-blind, Comparative, Randomized Tolerability, Safety and Immunogenicity Trial of the Flu-M® Inactivated Vaccine in Volunteers Aged 18 to 60 Years
St. Petersburg Research Institute of Vaccines and Sera16 个研究点 分布在 2 个国家目标入组 654 人开始时间: 2020年12月7日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 654
- 试验地点
- 16
- 主要终点
- Change from baseline geometric mean titer ratio of antibodies for each virus strain (GMT (Flu-M w/p) / GMT (Flu-M w/o/p) at 6 months
研究概览
简要总结
Comparative assessment of the tolerability, safety, and immunogenicity of the Flu-M® Inactivated Split Influenza Vaccine (without preservative) and the Flu-M® vaccine (with preservative) in volunteers aged between 18 and 60
详细描述
- Assessment of the tolerability and safety of the Flu-M® inactivated split influenza vaccine (without preservative) and Flu-M® (with preservative).
- Assessment of the immunogenicity of the Flu-M® inactivated split influenza vaccine (with preservative) and Flu-M® (without preservative).
Single administration of the trial products. Duration of follow-up - 28+3 (outpatient visit) and Long-term follow-up - 180±3 days.
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
- •Healthy volunteers (men and women) aged 18-60 years;
- •Written informed consent of volunteers to participate in the clinical trial;
- •Volunteers able to fulfill requirements of the Protocol (i.e. fill out the patient's diary, come to follow-up visits);
- •For fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception during the trial and at least two months after vaccination
- •For fertile men - consent to observe adequate methods of contraception during the trial and at least two months after vaccination, except for men after vasectomy with documented azoospermia, and their sexual partners should use methods of contraception that ensure more than 90% reliability or be incapable of conception after a surgical sterilization or have a natural menopause for at least 2 years.
排除标准
- •History of influenza/ARVI or previous influenza vaccination during 6 months before the trial;
- •Positive result of the SARS-CoV-2 test;
- •A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter) or complications (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions accompanied or not accompanied by a fever due to any previous vaccination);
- •Allergic reactions to vaccine components or any previous vaccination;
- •History of allergic reaction to chicken protein;
- •Guillain-Barré syndrome (acute polyneuropathy) in the medical history;
- •Previous vaccination with rabies vaccines less than 2 months before immunization or scheduled vaccination with rabies vaccines within 1 month after immunization with the trial vaccines;
- •Use of any vaccines within 1 month before the vaccination, excluding vaccines according to the National Calendar of Preventive Vaccination, including for epidemic reasons;
- •History of leukemia, cancer, autoimmune diseases;
- •(Positive blood test results for HIV, syphilis, hepatitis B/C;
- •Volunteers who received immunoglobulin or blood products or had a blood transfusion during the last three months before the trial;
- •History of long-term use (more than 14 days) of immunosuppressants or immunomodulatory drugs for six months before the trial;
- •History of any confirmed or suspected immunosuppressive or immunodeficiency condition;
- •History of chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, the gastrointestinal tract, liver, kidneys, hematopoietic or immune systems, mental disease in the acute stage or in the decompensation stage (recovery less than 4 weeks before vaccination);
- •Diabetes mellitus, thyrotoxicosis or other diseases of the endocrine system;
- •History of eczema;
- •Treatment with glucocorticosteroids, including in small doses, as well as local use of drugs containing steroids (> 10 mg of prednisolone or its equivalent for more than 14 days before the screening);
- •Tuberculosis, neurological or mental disorders, a convulsive syndrome, including in the past medical history;
- •History of acute infectious diseases (recovery less than 4 weeks before vaccination);
- •Consumption of more than 10 units of alcohol per week or history of alcohol addiction, drug addiction or abuse of pharmaceutical products;
- •Smoking of more than 10 cigarettes per day;
- •Participation in another clinical trial during the last 3 months;
- •Pregnancy or lactation;
- •Coagulopathy, including hemophilia;
- •Taking aspirin or other antiplatelet agents in high doses.
结局指标
主要结局
Change from baseline geometric mean titer ratio of antibodies for each virus strain (GMT (Flu-M w/p) / GMT (Flu-M w/o/p) at 6 months
时间窗: days 0-180
The upper limit of bilateral 95% CI for the GMT ratio (GMT (Flu-M w/p) / GMT (Flu-M w/o/p) should not exceed 1.5
Change from baseline the difference between seroconversion rates (seroconversion rate Flu-M w/p - seroconversion rate Flu-M w/o/p) at 6 months
时间窗: days 0-180
The upper limit of bilateral 95% CI for the difference between seroconversion rates (seroconversion rate Flu-M w/p - seroconversion rate Flu-M w/o/p) should not exceed 10%
次要结局
- Seroprotection rate for each virus strain (A (H1N1), A (H3N2) and B)(days 0,28,180)
- Number of patients with abnormal results of electrocardiography (ECG)(days 0,7)
- Incidence of serious adverse events (SAEs)(days 1-180)
- Number of patients with abnormal results of physical examination(days 0,1,7,28,180)
- Number of patients with abnormal results of neurological status(days 0,7,28)
- Determination of total IgE(days 0,7,28)
- Geometric mean titer of antibodies for each virus strain (A (H1N1), A (H3N2) and B)(days 0,28,180)
- Seroconversion factor for each virus strain (A (H1N1), A (H3N2) and B)(days 0,28,180)
- Incidence, severity, and duration of influenza or ARVI during 6 months after vaccination(days 1-180)
- Number of patients with abnormal results of blood pressure (BP)(days 0,1,7,28,180)
- Seroconversion rate for each virus strain (A (H1N1), A (H3N2) and B)(days 0,28,180)
- Incidence of adverse events (AEs)(days 1-180)
- Number of patients with abnormal results of body temperature (>37 °С)(days 0,1,7,28,180)
- Number of patients with abnormal results of heart rate (HR)(days 0,1,7,28,180)
- Number of patients with abnormal results of respiratory rate (RR)(days 0,1,7,28,180)
研究者
研究点 (16)
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