NCT00297856已完成不适用
Open, Prospective Study of the Safety of GSK Biologicals' Boostrix® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) Administered to a Cohort of Adolescents in a US Health Maintenance Organization (HMO)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Occurrence of medically-attended neurological events.
研究概览
简要总结
Pre-licensure studies of GSK Biologicals' Boostrix® have shown it to be generally safe and well-tolerated. This post-licensure study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
Data collection through utilization of automated databases at the study site. The collaborator is Kaiser Permanente Vaccine Study Center.
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
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects between the age of 10 and 18 years (inclusive) who received a dose of Boostrix and who have safety follow-up information available
排除标准
- 未提供
结局指标
主要结局
Occurrence of medically-attended neurological events.
时间窗: 30 days following vaccination with Boostrix.
次要结局
- Occurrence of allergic reactions.(30 days following vaccination with Boostrix)
- Occurrence of new onset chronic illnesses(6-month period following vaccination with Boostrix)
- Occurrence of neurological and hematological events and allergic reactions(Within the second 30-day period following vaccination with Boostrix)
- Occurrence of chronic illnesses in an historical control cohort of subjects vaccinated with Td vaccine
- Occurrence of medically-attended hematologic events(30 days following vaccination with Boostrix)
研究者
研究点 (1)
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