NCT01024725已完成不适用
Evaluation of a Vaccination Campaign With A(H1N1)v Pandemic Vaccines: a Prospective Cohort Study
Finnish Institute for Health and Welfare1 个研究点 分布在 1 个国家目标入组 3,518 人开始时间: 2009年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,518
- 试验地点
- 1
- 主要终点
- Effectiveness of vaccination in preventing the first episode of laboratory-confirmed A(H1N1)v infection in adults
研究概览
简要总结
A cohort of 4000 community-dwelling adults is followed to evaluate the effectiveness of the Finnish national A(H1N1)v influenza vaccination campaign in preventing the first episode of laboratory-confirmed A(H1N1)v influenza. The safety of vaccination and the severity of the disease are followed primarily from health care registers. In a subgroup of 200 participants, the humoral and cellular immunogenicity of the vaccine will be studied.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full legal competence;
- •Written informed consent obtained;
- •Assigned to use the services of Tampere health centre and community-dwelling;
- •At least 18 and no more than 75 years old, inclusive;
- •Belongs to the target group of A(H1N1)v vaccination in the region during the pandemic vaccination campaign;
- •Able to communicate fluently in Finnish or Swedish
- •Able to adhere to all protocol required study procedures without any special burden or risk, as judged by the investigator or designate.
排除标准
- •For the total study cohort, no specific exclusion criteria will be applied;
- •For the subgroup for follow-up of immunogenicity of the vaccine (immunogenicity cohort), exclusion criteria comprise:
- •previous severe allergic reaction to influenza vaccines or known severe allergy to the ingredients of the vaccine
- •previous severe allergic reaction to eggs
- •significant immunological disorder
结局指标
主要结局
Effectiveness of vaccination in preventing the first episode of laboratory-confirmed A(H1N1)v infection in adults
时间窗: 3 November 2009 to 30 April 2010
次要结局
- Safety of vaccination with the A(H1N1)v vaccine(3 November 2009 to 31 October-November 2010)
- Humoral and cellular immune responses to the vaccine (subgroup of 200 adults)(3 November 2009 to 31 October-November 2010)
- Severity and possible complications of the A(H1N1)v influenza(3 November 2009 to 31 October-November 2010)
- Effectiveness of the vaccine in subgroups(3 November 2009 to 31 October-November 2010)
研究者
研究点 (1)
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