Immune Response Study of Influenza Vaccine
Humoral and Cellular Immune Response Study of Influenza Vaccine
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine
大体时间：one year
|
one year
|
合作者和调查者
调查人员
- 首席研究员：jiang wu, Bachelor、Beijing Centers for Disease Control and Prevention
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.