Immunogenicity and Safety of a Quadrivalent Influenza Vaccine in Participants Aged Above 3 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,688
- 试验地点
- 2
- 主要终点
- Number of participants that presented seroconversion post injection
研究概览
简要总结
The aim of this study is to assess the immunogenicity and safety of a quadrivalent influenza vaccine compared with a trivalent influenza vaccine in participants aged above 3 years.
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over the age of three years,healthy population
- •Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required
- •To comply with the requirements of clinical trial program
- •Temperature≤37.0℃ on day of enrollment
排除标准
- •A history of influenza virus infection or suspected infection Abnormal blood routine, blood biochemistry and urine routine examination indexes in last three months
- •Any prior administration of influenza vaccine in last six months
- •Allergy to any component in the vaccine, especially for egg allergy
- •Allergy history of any previous vaccination or drug
- •Acute episodes of chronic illness or acute illness on the day of vaccination
- •Received a live vaccine within fourteen days prior to receiving the vaccine, or received a subunit or inactivated vaccine within seven days
- •Congenital or acquired immune deficiencies, or treatment with immunosuppressive agents, such as long-term treatment with systemic corticosteroids
- •Suffering from severe chronic diseases (such as Down's syndrome, diabetes, sicklemia or neurological disorders, Green's Barre syndrome)
- •Asthma, required urgent treatment in last two years
- •The blood products were received prior to the acceptance of the vaccine
- •Known or suspected of respiratory disease, acute infection or chronic disease active period, HIV infection, cardiovascular disease, severe hypertension, malignant tumor during treatment, skin diseases
- •History of epilepsy, convulsions, or a family history of psychosis
- •Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities), or obvious bruising or coagulopathy
- •Plan to move or leave the area for an extended period of time before the end of the study
- •Under anti-tb treatment
- •Any prior administration of other research medicine/vaccine in last one month
- •Women are pregnant or in the near future planned pregnancy or pregnancy test positive
结局指标
主要结局
Number of participants that presented seroconversion post injection
时间窗: 30 days after inoculation
* Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more. * Participants will be collected blood post first study injection, when blood samples will be taken for HI testing
Geometric mean of Hemagglutination-inhibition titre post first study injection
时间窗: 30 days after inoculation
* Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants post first study injection. * Participants will be collected blood post first study injection, when blood samples will be taken for HI testing.
次要结局
- Number of participants that presented seroprotection post injection(30 days after inoculation)
- Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)(Continuous observation for 30 days after two inoculations)