NCT01063608已完成4 期
Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Clinical Staff (FLU-HOP)
Institut National de la Santé Et de la Recherche Médicale, France2 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2009年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- Evaluation of the intensity of the humoral and cellular immune responses of the anti-A(H1N1)v vaccine in a medical care population as a function of the age and of the prior seasonal anti-influenza vaccinations.
研究概览
简要总结
This project may help to answer several fundamental questions related to public health regarding vaccination against influenza viruses and regarding the influenza A(H1N1)v pandemy:
What is the immunologic efficacy in terms of antibodies response of the vaccination against the seasonal (2009-2010) influenza virus and against the A(H1N1)v virus in the clinical staff?
Moreover, it may help to answer questions related to the use of a vaccine against influenza virus variants emerging in the French population:
- Before the vaccination:
- What is the status of the residual anti-H1N1 seasonal viruses immunity and of the anti-A(H1N1)v immunity in the population stratified by age and taking into account the multiplicity of the prior seasonal vaccinations?
- What is the level of the cellular and humoral cross-reactivity between the different H1N1 strains?
- After the vaccination:
- What is the intensity of the anti-vaccine immune response as a function of the age of the population ad of the prior seasonal vaccinations?
- What is the level of the cellular and humoral cross-reactivity after vaccination as a function of the age of the population and of the multiplicity of the prior seasonal vaccinations?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Age superior or equal to 20 years
- •Women with childbearing potential using contraception
排除标准
- •Documented immune depression
- •Current immunosuppressive therapy
- •Pregnancy (documented by a positive pregnancy test)
- •Breast feeding women
- •Documented allergy or hypersensitivity to vaccines
- •Documented acute or chronic inflammatory disease
- •Concomitant participation to another clinical trial
研究组 & 干预措施
Anti-H1N1v Vaccine
Experimental
干预措施: Anti-H1N1v Vaccine (Biological)
结局指标
主要结局
Evaluation of the intensity of the humoral and cellular immune responses of the anti-A(H1N1)v vaccine in a medical care population as a function of the age and of the prior seasonal anti-influenza vaccinations.
时间窗: 5 months
次要结局
- Investigate the quality of the humoral and cellular immune responses induced by the seasonal anti-influenza vaccine as a function of the age and of the prior seasonal vaccinations.(5 months)
- Determine the cross-reactivity of the humoral and cellular immune responses as a function of the age and of the prior seasonal vaccinations(5 months)
- Assess the tolerance to the seasonal and pandemic vaccines(5 months)
- Assess the occurence of flu episodes and their severity during the 2009-2010 season as a function of the age of the population. Then, the correlation between the flu episodes and and the immunologic results is to be evaluated.(5 months)
- Evaluate the perception of the anti-influenza vaccination in a medical care population in the current H1N1v pandemy context.(5 months)
研究者
研究点 (2)
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