NCT06385821已完成3 期
Multicenter, Double-blind, Randomized, Parallel Group Study to Evaluate the Immunogenicity, Reactogenicity and Safety of the Grippol® Quadrivalent Vaccine in Children Aged 6 Months to 5 Years (Inclusive)
NPO Petrovax28 个研究点 分布在 2 个国家目标入组 824 人开始时间: 2022年9月21日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 824
- 试验地点
- 28
- 主要终点
- To prove non-inferior immunogenicity of the Grippol Quadrivalent vaccine when compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three matching strains of the compared vaccines
研究概览
简要总结
The goal of this clinical study is to prove the no less immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of the "proportion of vaccinated with seroconversion in paired sera of the hemagglutination inhibition reaction obtained before and after vaccination".
详细描述
The main questions it aims to answer are:
- To compare the immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of "geometric mean antibody titers after vaccination"
- Evaluate the immunogenicity of the Grippol Quadrivalent vaccine and the Grippol plus vaccine according to the following indicators:
- Proportion of those vaccinated with seroconversion and geometric mean titer of antibodies to the fourth additional strain of compared vaccines
- Multiplicity of the increase in the geometric mean titer of antibodies to 4 strains of the influenza virus in paired sera of the hemagglutination inhibition reaction after vaccination in relation to the initial values of antibody titers
- Seroprotection (proportion (%) vaccinated with antibody titer ≥ 1:40 to 4 strains of influenza virus in paired sera of the hemagglutination inhibition reaction after vaccination)
- Evaluate the effectiveness of the Grippol Quadrivalent vaccine and the Grippol plus vaccine according to the following indicators:
- Incidence of Influenza and ARI (Month 1-Month 6 after vaccination)
- Severity and duration of reported cases of influenza and ARI, presence of complications
- Assess the reactogenicity of the Grippol Quadrivalent vaccine and the Grippol plus vaccine in children aged 6 months to 5 years (inclusive):
- Frequency and nature of general and local post-vaccination reactions (7-day follow-up period after vaccine administration)
- Assess the safety of Grippol Quadrivalent and Grippol Plus in children aged 6 months to 5 years (inclusive)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female children aged 6 months to 5 years inclusive at the time of vaccination.
- •Availability of Informed consent to participate in the study, signed by one of the parents.
- •The diagnosis is "healthy", established according to standard clinical, laboratory and instrumental methods of examination carried out at screening, according to the assessment of the researcher, as well as anamnesis data (absence of acute and chronic diseases of the respiratory, cardiovascular, nervous systems, dysfunction liver or kidneys).
- •Negative result of a rapid test for SARS-CoV-2 antigen at screening.
- •For children aged 6 to 11 months inclusive: children born at gestational age ≥37 weeks weighing ≥2.5 kg.
- •Parental consent to cooperate in good faith with the investigator and center staff, attend scheduled visits, complete the self-monitoring diary, and follow the protocol.
排除标准
- •Vaccination with any influenza vaccine within the previous 6 months. Vaccination with other vaccines, according to the national vaccination schedule, is allowed no later than 30 days before the introduction of the study vaccine, and no earlier than 30 days after the administration of the study vaccines.
- •Participation in a clinical trial of a vaccine, medicinal product, or medical device less than 30 days prior to screening.
- •Hypersensitivity to any of the components of the studied vaccines or severe post-vaccination complications to any vaccine in history.
- •The presence at the time of screening of acute infectious diseases of any localization, or the presence of a history of acute infectious and non-infectious diseases less than 14 days before screening.
- •Body temperature in the armpit ≥37.0°C at screening or before the introduction of the vaccine.
- •History of significant chronic diseases, such as malignant neoplasms or blood diseases, autoimmune diseases, insulin-dependent diabetes mellitus, chronic diseases of the lungs, liver or kidneys, cardiovascular, nervous systems, secondary, primary and induced immunodeficiency, HIV- infections, as well as other significant, according to the researcher, diseases.
- •A history of seizures or a progressive neurological disease.
- •History of Guillain-Barré syndrome (post-infectious demyelinating polyradiculoneuropathy of autoimmune etiology).
- •Use of antipyretics, including non-steroidal anti-inflammatory drugs less than 24 hours before screening and vaccination; antibacterial drugs of systemic action - less than 72 hours before screening and vaccination; anticoagulants - less than 3 weeks before screening and vaccination; immunoglobulins, blood products - less than 3 months before screening and vaccination; long-term use of systemic corticosteroids (prednisolone or equivalent for more than 2 consecutive weeks) - less than 3 months before vaccination screening.
- •Surgery performed less than 3 months prior to screening.
- •Children of research team members or research facility staff involved in this clinical trial.
- •Orphans, children left without parental care.
- •Any other medical or social condition that, in the opinion of the investigator, precludes the participation of the child in this study.
结局指标
主要结局
To prove non-inferior immunogenicity of the Grippol Quadrivalent vaccine when compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three matching strains of the compared vaccines
时间窗: Baseline to Day 25±3
Proportion of vaccinated seroconverters in paired hemagglutination inhibition test sera obtained before and after vaccination Seroconversion is defined as: 1. increase in antibody titer to influenza virus strains to ≥ 1:40 (with initial antibody titer \< 1:10); or 2. an increase in antibody titer by 4 or more times compared to the initial titer (with an initial antibody titer ≥ 1:10) in paired sera RTGA after vaccination. The initial antibody titer will be the titers of antibodies to influenza virus antigens in the hemagglutination inhibition reaction obtained during screening. Post-vaccination titres will be those obtained on Day 25±3 after a single dose of vaccine in children 36 months to 5 years of age or a second dose of vaccine in children 6 to 35 months of age.
次要结局
- The severity and duration of registered cases of influenza and acute respiratory infections (ARI), the presence of complications(Month 1 to Month 6)
- To assess the reactogenicity of the vaccine Grippol Quadrivalent and the vaccine Grippol plus(First 7 days after vaccination)
- Frequency and nature of medically attended AEs(Baseline to month 6)
- Incidence of influenza and acute respiratory infections (ARI)(Month 1-6)
- Geometric mean antibody titers(Baseline to Day 25±3)
- Multiplicity of the increase in the geometric mean titer(Baseline to Day 25±3)
- Proportion of those vaccinated with seroconversion and geometric mean titer(Baseline to Day 25±3)
- Seroprotection(Baseline to Day 25±3)
- Frequency and nature of SAEs(Baseline to month 6)
研究者
研究点 (28)
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