An Open Phase IV Clinical Trial of Quadrivalent Influenza Virus Split Vaccine to Evaluate the Safety and Immunogenicity in Healthy Population Aged 3-8 Years
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- The proportion of all adverse reactions/events
研究概览
简要总结
To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy population aged 3-8 years following different immunization procedures.
详细描述
To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy population aged 3-8 years following different immunization procedures, and the participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at day 0 and 28.
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
盲法说明
Open Label
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
- •Healthy children aged 3-8 years. Volunteers are required to show vaccination certificate if they have not received a previous flu vaccine.
- •Volunteers' legal guardian or client informed consent, voluntarily participate in and sign informed consent. (Volunteers over the age of 8 also need informed consent and signature)
- •Volunteers' legal guardian or client has the ability (non-illiterate) to understand the study procedures, to use a thermometer, scale, and fill in a diary card as required, and be able to complete the clinical study in compliance with the clinical trial protocol.
排除标准
- •The axillary temperature greater than 37.0℃ on the day of enrollment;
- •Have suffered from influenza within previous 3 months or suffering currently (confirmed by either clinical, serological or microbiological methods);
- •Have received any influenza vaccine (registered or experimental) within 6 months or be going to receive other influenza vaccine during the study period;
- •Allergic to any component of the vaccine, or have a history of allergic reactions to gentamicin sulfate;
- •A history of severe allergy to any vaccine or drug, or with a history of nervous system damage;
- •Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
- •Acute illness, severe chronic illness or acute attack of chronic disease on the day of vaccination;
- •A history of live attenuated vaccination within 14 days prior to vaccination and a history of other vaccinations within 7 days prior to vaccination;
- •Received immunoenhancement or inhibitor therapy within 3 months (continued oral or intravenous administration for more than 14 days);
- •Congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
- •Have a history of asthma, the condition has been unstable for past two years and require treatment, such as emergency treatment, hospitalization, intubation or oral or intravenous administration of corticosteroids and so on;
- •Have received blood or blood-related products;
- •A history of convulsion, epilepsy, encephalopathy, guillain-barre syndrome, a history of mental illness or have a mental illness family history;
- •A history of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease);
- •Planning to relocate before the end of the study or to leave for an extended period during the scheduled study visit;
- •Participating in or planning to participate in other clinical trials in the near future;
- •Any conditions judged by investigators that were inappropriate for participation in this clinical trial.
- •Receiving the second dose of vaccine
- •Have a severe allergic reaction after receiving the first dose of vaccine;
- •Serious adverse events occurred that were causally related to the first dose of vaccine injection；
- •After receiving the first dose of vaccine, the researchers will decide whether the volunteer should participate in the study continued or not if the newly discovered feature or newly condition occurred on volunteer that do not meet the inclusion criteria or meet the exclusion criteria;
- •Other reasons for exclusion considered by the investigator.
结局指标
主要结局
The proportion of all adverse reactions/events
时间窗: up to 56 days
The proportion of all adverse reactions/events in subjects through 28 days after the second dose.
seroconversion rate of hemagglutination inhibition (HI) antibodies
时间窗: up to 56 days
28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. Seroconversion rate of HI antibodies against any subtype of influenza virus in each group.
seroprotection rate of HI antibodies
时间窗: up to 56 days
28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. Seroprotection rate of HI antibodies against any subtype of influenza virus in each group.
geometric mean increase (GMI) of HI antibodies
时间窗: up to 56 days
28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. GMI of HI antibodies against any subtype of influenza virus in each group.
次要结局
- p value of difference of GMI in subjects with different immunization procedures(up to 56 days)
- Reactogenicity Events(208 days)
- p value of difference of seroconversion rate in subjects with different immunization procedures(up to 56 days)
- p value of difference of seroprotection rate in subjects with different immunization procedures(up to 56 days)