EUCTR2009-015700-26-FI进行中(未招募)不适用
Evaluation of a vaccination campaign with A(H1N1)v pandemic vaccines: a prospective cohort study.A(H1N1)v-pandemiarokotuskampanjan vaikutukset - Pandemiarokotuskampanjatutkimus
ational Institute for Health and Welfare0 个研究点目标入组 4,000 人开始时间: 2009年9月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 4,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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:
- •oprevious severe allergic reaction to influenza vaccines or known severe allergy to the ingredients of the vaccine
- •oprevious severe allergic reaction to eggs
- •osignificant immunological disorder
研究者
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