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临床试验/EUCTR2009-015700-26-FI
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

发起方
ational Institute for Health and Welfare

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