A Clinical Trial to Assess Immunogencity and Safety of 2 Doses of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years
试验速览
- 阶段
- 4 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse Reactions (ARs)
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 months through 8 years who have previously received ≥2 total doses of trivalent or quadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose of influenza vaccine. For those who have not previously received ≥2 doses of trivalent or quadrivalent influenza vaccine, they require 2 dose of influenza vaccine. but the evidence on how to select vaccine doses for quadrivalent influenza vaccine is limited in China. The study is a prospective, open-label comparison of the immunogenicity and reactogenicity of 1 versus 2 doses of an inactivated quadrivalent influenza vaccine in subjects of 3-8 years old with different 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 receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeks after dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2, A/H1N1, and B antigens included in the vaccine were measured at each time point
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 the informed consent
- •Subjects themselves or their guardians can and will comply with the requirements of the protocol
- •Subjects have received ≥2 doses of trivalent or quadrivalent infuenza vaccine before enrollment (Doses need not have been received during same or consecutive seasons); Subjects have not received infuenza vaccine before enrollment
- •Subjects with temperature <=37.0°C on axillary setting
排除标准
- •Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
- •Subject who is allergic to any ingredient of the vaccine
- •Subject with damaged or low immune function which has already been known
- •Subject with acute febrile illness or infectious disease
- •Major congenital defects or serious chronic illness, including perinatal brain damage
- •Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection
- •Subject who has serious allergic history
- •Subject who developed guillain-Barre syndrome post influenza vaccination
- •Any prior administration of immunodepressant or corticosteroids in last 6 months
- •Any prior administration of influenza vaccine in last 6 month
- •Any prior administration of blood products in last 3 months
- •Any prior administration of other research medicine/vaccine in last 30 days
- •Any prior administration of any attenuated live vaccine in last 14 days
- •Any prior administration of subunit or inactivated vaccines in last 7 days, such as pneumococcal vaccine
- •Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent for subject's guardian
结局指标
主要结局
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
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 \< 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
次要结局
- Number of participants with Serious Adverse Events (SAE)(6 months after the last vaccination)
- the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination≥70%(day 28 after dose 2)
- Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5(day 28 after dose 2)
- Number of participants with Adverse Events (AEs)(28 days after each vaccination)