Randomized, Double-blind, Comparative, Controlled Trial of Tolerability, Reactogenicity, Safety and Immunogenicity of Flu-M [Inactivated Split Influenza Vaccine] in Pregnant Women During the 2nd - 3rd Trimester
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 5
- 主要终点
- Change from Baseline Seroconversion rate at day 21 after vaccination
研究概览
简要总结
Comparative study of tolerability, reactogenicity, safety and immunogenicity Flu-M [Inactivated Split Influenza Vaccine] vs. the Ultrix® vaccine for the prevention of influenza in pregnant women in the 2nd-3rd trimesters of pregnancy
详细描述
This is a randomized, double-blind, comparative, controlled trial. A design with a control group treated with Ultrix®, inactivated influenza vaccine, was chosen to obtain objective findings.Trial population: healthy women aged 18 to 35 years during the 2nd and 3rd trimesters of pregnancy. Subjects were randomized into 4 groups in a ratio of 1:1:1:1, 50 subjects per group.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Presence of signed Informed Consent of the female patient to participate in the trial
- •Healthy women aged 18 to 35 years in their 2nd and 3rd trimesters of pregnancy with gestational age of no more than 32 weeks
- •Singleton pregnancy progressing normally
- •No contraindications for vaccination
- •Pregnant women that are able to fulfill the requirements of the protocol (i.e., fill out the Self-Observation Diary, come to follow-up visits)
- •The investigator is given the opportunity to collect data about somatic, infectious, and allergic diseases within at least 3 months from vaccination (one or more calls from the clinical investigator or visits per month (as needed))
排除标准
- •Body temperature above 37°С
- •History of influenza or previous influenza vaccination during 6 months before the screening
- •History of allergic reactions to chicken protein
- •Allergic reactions to vaccine components or any previous vaccination
- •Gestational toxicosis
- •Any disorders of pregnancy
- •Thyroid disorders
- •Bronchial asthma
- •Clotting disorders
- •1, 2 type diabetes mellitus
- •High risk of fetal chromosomal abnormalities (individual risk of at least 1/100) in the 1st trimester of pregnancy and/or the detection of fetal congenital anomalies / developmental defects in the 1st, 2nd, and 3rd trimesters of pregnancy
- •Strong 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 from prior vaccination; convulsions accompanied or not accompanied by a fever due to any prior vaccination
- •Acute infectious or non-infectious diseases less than 4 weeks before the screening, exacerbation of chronic diseases (the vaccination can be carried out after recovery or in the period of remission)
- •Immunomodulatory therapy, including immune-enhancing, immunosuppressive therapy (corticosteroids, cytotoxic and radioactive drugs) in the 6 months preceding the trial
- •Any other contraindications against vaccination according to the investigator.
- •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 trial
- •History of Guillain-Barré syndrome (acute polyneuropathy)
- •Autoimmune diseases
- •Any confirmed or suspected immunosuppressive or immunodeficiency condition
- •Respiratory, cardiovascular failure, impaired liver or kidney function.
- •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
- •Vaccination with any vaccine less than 30 days before the screening or scheduled vaccination with any vaccine within 30 days from vaccination with the trial vaccines
- •The woman is/was a patient of a tuberculosis dispensary and/or narcological dispensary and/or neuropsychiatric dispensary
- •Chronic alcohol abuse and/or use of drugs in the past history
- •Participation in another clinical trial during the last 3 months
研究组 & 干预措施
Flu-M, II trimester of pregnancy
Subjects during their II trimester of pregnancy (gestational age: 14-26 weeks), immunized once with the Flu-M vaccine.
干预措施: Flu-M, Inactivated split influenza vaccine (Biological)
Ultrix®, II trimester of pregnancy
Subjects during their II trimester of pregnancy (gestational age: 14-26 weeks), immunized once with Ultrix®.
干预措施: Ultrix®, Inactivated Split Influenza Vaccine (Biological)
Flu-M, III trimester of pregnancy
Subjects during their III trimester of pregnancy (gestational age: 27-32 weeks), will be immunized once with the Flu-M vaccine.
干预措施: Flu-M, Inactivated split influenza vaccine (Biological)
Ultrix®, III trimester of pregnancy
Subjects during their III trimester of pregnancy (gestational age: 27-32 weeks), immunized once with Ultrix®.
干预措施: Ultrix®, Inactivated Split Influenza Vaccine (Biological)
结局指标
主要结局
Change from Baseline Seroconversion rate at day 21 after vaccination
时间窗: Days 0 (screening), 21
The relative number of vaccinees, whose titer of hemagglutinin inhibiting antibodies has increased by more than 4 times vs. baseline among all immunoprotective persons. Antibodies to influenza B, А (H1N1), А (H3N2) viruses Seroconversion rate ≥ 40%
Change from Baseline Seroconversion factor at day 21 after vaccination
时间窗: Days 0 (screening), 21
An increase in the geometric mean titers of hemagglutinin inhibiting antibodies on Day 21 vs. baseline, expressed in multiplicity of increase. Antibodies to influenza B, А (H1N1), А (H3N2) viruses Seroconversion factor ≥ 2.5
Change from Baseline Seroprotection rate at day 21 after vaccination
时间窗: Days 0 (screening), 21
The percentage of vaccinees who have an antibody titer of more than 1:40 by Day 21 after vaccination. Antibodies to influenza B, А (H1N1), А (H3N2) viruses Seroprotection rate ≥ 70%.
次要结局
- Number of participants with abnormal changes in physical examination data(Days 0-7, day 21)
- Incidence of AEs and SAEs associated with vaccination(Day 1 (30 minutes, 3 and 5 hours after vaccination), days 2-21)
- Number of participants with abnormal changes of neurological examination data(Days 0-7, day 21)
- Number of participants with clinically significant abnormalities - Biochemical blood test (BBT)(Days 0 (screening), 3, 21)
- Number of participants with abnormal changes in vital signs - Blood pressure (BP)(Days 0-7, day 21)
- Number of participants with abnormal changes in vital signs - Heart rate (HR)(Days 0-7, day 21)
- Number of participants with abnormal changes in vital signs - Respiratory rate (RR)(Days 0-7, day 21)
- Number of participants with abnormal changes in vital signs - Body temperature(Days 0, 1 (10 minutes before vaccination, 30 minutes and 2 and 5 hours after vaccination), days 2-7, day 21)
- Incidence and severity of local post-injection reactions(Day 1 (30 minutes, 3 and 5 hours after vaccination), days 2-21)
- Number of participants with abnormal changes data obtained from examinations by immunologist-allergist(Days 1-7, day 21)
- Number of participants with abnormal changes in the ultrasound data assessment of fetus and uterus(Days 0 (screening), 21)
- Number of participants with clinically significant abnormalities - Complete blood count (CBC)(Days 0 (screening), 3, 21)
- Number of participants with clinically significant abnormalities - Urinalysis(Days 0 (screening), 3, 21)
- Number of participants with abnormal changes of total IgE(Days 0 (screening), 3, 21)
- Incidence and severity of systemic post-injection reactions(Day 1 (30 minutes, 3 and 5 hours after vaccination), days 2-21)
- Number of participants with abnormal changes data obtained from examinations by obstetrician-gynecologist(Days 0-7, day 21)