NCT00996853已完成不适用
Post-Authorization Safety Study (PASS) of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK2340272A) in the United Kingdom (UK)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,206
- 试验地点
- 1
- 主要终点
- Medically-attended adverse events
研究概览
简要总结
The focus of this study is to assess the safety of GSK's H1N1 vaccine in real life conditions as soon as the vaccine is used, in a mass vaccination programme, and with a system for rapid generation, communication and evaluation of safety data.
This study is a commitment to the European Medicines Agency (EMEA), as part of GlaxoSmithKline Biologicals' (GSK Biologicals') risk management plan for pandemic influenza vaccination.
详细描述
Collaborator: Medicines and Healthcare products Regulatory Agency
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent, and assent where appropriate, obtained from the subject/from the subject's parent(s)/ Legally Acceptable Representative(s) (LAR).
- •A male or female subject vaccinated with a first dose of GSK Biologicals' H1N1 pandemic influenza vaccine
- •shortly (<24h) before being recruited in the study, and
- •within a GP practice participating in the study and where the subject is registered.
- •Subjects who the Investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol
排除标准
- •Subjects already vaccinated with any other H1N1 pandemic vaccine before study enrolment.
- •Child in care
结局指标
主要结局
Medically-attended adverse events
时间窗: Within one month after any dose
次要结局
- Adverse events solicited to assess reactogenicity(Within seven days after any dose)
- Serious adverse events and adverse events of special interest(Within six months after the second vaccine dose or within a maximum of eight months after the first dose)
- Pregnancy outcomes(Within two months after vaccination (last menstrual period up to 45 days after any dose))
研究者
研究点 (1)
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