NCT00950456已完成不适用
A Prospective Non-Interventional Observational Study to Assess the Safety of Two Vaccinations of a Vero Cell-Derived, Whole Virus H1N1 Pandemic Influenza Vaccine in Subjects Exposed to the Vaccine Through Policies by Governments or Health Authorities
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,216
- 试验地点
- 7
研究概览
简要总结
The purpose of this observational study, which will be initiated as soon as the licensed H1N1 Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the incidence of any medically-attended adverse events in all vaccinated subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects, per indication on license or per official vaccine recommendations, will be eligible for participation in this study if:
- •They will be administered CELVAPAN (= Baxter´s H1N1 pandemic influenza vaccine)
- •They are 2 months of age or older at the time of first vaccine administration
- •Their medical history is available
- •The investigator believes they will comply with the foreseen vaccination schedule and will reliably observe signs or symptoms of adverse events during the observational period
- •They and/or their parent(s)/legal guardian(s) provide written informed consent, and assent where appropriate, prior to study entry according to national law
排除标准
- •Male and female subjects will be excluded from participation in this study if:
- •They have already been administered another H1N1 pandemic vaccine
- •They have any contraindication to vaccination (as per the Summary of Product Characteristics and/or relevant national immunization guidelines)
研究者
研究点 (7)
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