Humoral and Cellular Immune Response Study of Influenza Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 主要终点
- the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine
研究概览
简要总结
An observational clinical study will be performed in subjects aged 12-60 years old to describe the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine, and to discuss the role of different antibodies against influenza virus infection, and to look for possible factors related to side effects with the vaccine.
详细描述
A randomized clinical trial will be conducted to describe immune response of seasonal influenza virus vaccine in a single center in China. 200 subjects aged 18-60 years will be enrolled under the premise of informed consent and receive one dose of vaccine. All vaccinations will be done by specific study personnel, who do not take part in the assessment of safety or immunogenicity. Adverse events will be recorded after vaccination and blood samples were collected at 0,7,14,28 days for antibody detection and split vaccine neutralizing antibody detection, determination of cellular immune function in the same time.
The clinical program approved by the ethics committee will be performed by the researchers independently. Inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 12-60 years old
- •male or non-pregnant female
- •volunteers
- •clinically healthy as determined by: medical history inquiring and physical examination
- •provide written informed consents before joining the trial
排除标准
- •infected with Influenza A virus subtype H1N1(2009),
- •vaccinated with seasonal influenza vaccine,
- •allergic to any ingredient of vaccine,
- •autoimmune disease or immunodeficiency,
- •active malignancy,
- •bleeding disorder,
- •seizure disorder,
- •Guillain-Barre Syndrome,
- •treatment with cytotoxic or immunosuppressive drugs within the past 6 months,
- •receipt of blood products within the past 3 months,
- •administration of any other investigational research agents or live attenuated vaccine within 30 days,
- •administration of subunit or inactivated vaccines within 14 days,
- •axillary temperature over 37.0℃ at the time of vaccination.
结局指标
主要结局
the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine
时间窗: one year
次要结局
未报告次要终点
研究者
Wu Jiang
Centers for Disease Control and Prevention, China
Centers for Disease Control and Prevention, China