A Clinical Trial to Assess Immunogencity and Safety of 2 Doses of anInactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8Years
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI)antibodies against each virus strain after 2nd vaccination ≥40%
研究概览
简要总结
Routine annual influenza vaccination is recommended for all persons aged≥6 months who do not have contraindications. For those aged 6 monthsthrough 8 years who have previously received ≥2 total doses of trivalent orquadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose ofinfluenza vaccine. For those who have not previously received ≥2 doses oftrivalent or quadrivalent influenza vaccine, they require 2 dose of influenzavaccine. but the evidence on how to select vaccine doses for quadrivalentinfluenza vaccine is limited in China. The study is a prospective, open-labelcomparison of the immunogenicity and reactogenicity of 1 versus 2 doses ofan inactivated quadrivalent influenza vaccine in subjects of 3-8 years old withdifferent history of influenza vaccination.
详细描述
Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.Blood samples were obtained from children at 3 time points-before receiptof dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeksafter dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2,A/H1N1, and B antigens included in the vaccine were measured at each timepoint
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 3-8 years old
- •Healthy subjects judged from medical history and clinical examination
- •Subjects themselves or their guardians able to understand and sign theinformed consent
- •Subjects themselves or their guardians can and will comply with therequirements of the protocol
- •Subjects have received ≥2 doses of trivalent or quadrivalent infuenzavaccine before enrollment (Doses need not have been received duringsame or consecutive seasons); Subjects have not received infuenzavaccine before enrollment
- •Subjects with temperature <=37.0°C on axillary setting
排除标准
- •Any prior administration of other research medicine/vaccine in last 30 days
- •Any prior administration of influenza vaccine in last 6 month
- •Any prior administration of immunodepressant or corticosteroids in last 3 months
- •Any prior administration of blood products in last 3 months
- •Any prior administration of any attenuated live vaccine in last 14 days
- •Any prior administration of subunit or inactivated vaccines in last 7 days
- •Subject who developed guillain-Barre syndrome post influenza vaccination
- •Subject who is allergic to any ingredient of the vaccine
- •Subject with acute febrile illness or infectious disease
- •Thrombocytopenia, blood coagulation disorder or bleeding difficulties withintramuscular injection
- •Subject with damaged or low immune function which has already beenknown
- •Subject with congenital heart disease or other birth defects unsuitable for vaccination.
- •Subject with respiratory diseases (including pneumonia, tuberculosis, severe asthma, etc.), heart, liver and kidney diseases, mental disorders, or chronic infections.
- •Any medical, psychological, social or other condition judged byinvestigator, that may interfere subject's compliance with the protocol
结局指标
主要结局
the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI)antibodies against each virus strain after 2nd vaccination ≥40%
时间窗: day 28 after dose 2
The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
Number of participants with Adverse Reactions (ARs)
时间窗: 28 days after each vaccination
Frequency and severity of ARs for 28 days after each vaccination
次要结局
- Number of participants with Adverse Events (AEs)(28 days after each vaccination)
- Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5(day 28 after dose 2)
- the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination≥70%(day 28 after dose 2)
- Number of participants with Serious Adverse Events (SAE)(6 months after the last vaccination)