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
研究组 & 干预措施
Quadrivalent influenza vaccine
Subjects received 2 doses of 0.5 mL of quadrivalent influenza vaccine, 4 weeks apart. Each 0.5-ml dose contained 15 μg of hemagglutinin per strain.
干预措施: Quadrivalent influenza vaccine (Biological)
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)