NCT01037855已完成不适用
A Prospective Observational Study of Safety and Occurrence of Influenza-like Illness Following Administration of Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine Celtura
Novartis Vaccines9 个研究点 分布在 3 个国家目标入组 4,028 人开始时间: 2009年12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
- 4,028
- 试验地点
- 9
- 主要终点
- To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects
研究概览
简要总结
This is an observational study of safety and occurrence of influenza-like illness following administration of flu cell culture derived adjuvanted swine origin A (H1N1) pandemic subunit vaccine in subjects 6 months of age and older.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 6 months
- •Subjects will be vaccinated with Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine, independently of this study.
- •Subjects or parent/guardian willing to provide informed consent prior to vaccination administration and complete all of the study, including follow-up contact
排除标准
- •Received any prior H1N1 vaccination
结局指标
主要结局
To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects
时间窗: 6 months
To quantify the safety of Flu Cell Culture Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects
时间窗: 6 months
次要结局
- To assess the occurrence of laboratory confirmed H1N1sw and influenza-like illness following vaccination(6 Months)
研究者
研究点 (9)
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