NCT00146835已完成不适用
Phase IV, Prospective Study of the Safety of GSK Bios' Pediarix Administered to a Cohort of Infants in a US Health Maintenance Organization (HMO). (Post-Marketing PEDIARIX Safety Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120,794
- 主要终点
- All seizures following the primary doses of PEDIARIX in Cohort A and DTaP vaccine in Cohort B
研究概览
简要总结
Pre-licensure studies of GSK Biologicals' PEDIARIX vaccine have shown it to be generally safe and unlikely to result in vaccine-associated serious adverse events. This post-licensure study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort.
详细描述
- The outcomes to be assessed include the occurrence of all seizures (with or without fever), medically-attended fever, seizures associated with fever, allergic reactions, outpatient visits and hospitalizations for any cause, and all deaths.
- Data collection through utilization of automated databases at the study site with subset medical record review. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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 Weeks 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
All seizures following the primary doses of PEDIARIX in Cohort A and DTaP vaccine in Cohort B
时间窗: During the 8-day period following the primary dose
Medically-attended fever following the first dose of PEDIARIX in Cohort A and DTaP vaccine in Cohort B
时间窗: Within 4 days following the first dose
次要结局
- All seizures following the primary doses of PEDIARIX or DTaP vaccine(Day 21-41, in Cohort A; Day 0-7, in Cohort C)
- Medically-attended fever(Day 0-3 after 2nd and 3rd doses of PEDIARIX in Cohort A;Day 0-3 after 2nd and 3rd doses of DTaP vaccine in Cohort B;Day 21-41 after primary doses of PEDIARIX in the Cohort A;Day 0-3 after primary doses of DTaP vaccine in the Cohort C)
- Seizures associated with fever following the primary doses of PEDIARIX or DTaP vaccine(Day 0-3 after 2nd and 3rd doses of PEDIARIX in Cohort A;Day 0-3 after 2nd and 3rd doses of DTaP vaccine in Cohort B;Day 21-41 after primary doses of PEDIARIX in the Cohort A;Day 0-3 after primary doses of DTaP vaccine in the Cohort C)
- Allergic reactions, in cohorts A, B & C(0 to 48 hours following the primary doses of PEDIARIX or DTaP vaccine)
- Outpatient visits for any cause following the primary doses of PEDIARIX or DTaP vaccine(Day 0-20, Cohort A; Day 0-20, Cohort B; Day 21-41, Cohort A; Day 0-20, Cohort C)
- Hospitalizations for any cause following the primary doses of PEDIARIX or DTaP vaccine(Day 0-20, Cohort A, Day 0-20, Cohort B; Day 21-41, Cohort A; Day 0-20, Cohort C)
- Hospitalizations for any cause following PEDIARIX or DTaP vaccine(Day 0 post dose 1 to Day 41 following the last dose and from Day 42 post last dose to 1 year following the last dose)
- Deaths(Day 0 post dose 1 to Day 41 following the last dose and from Day 42 post last dose to 1 year following the last dose)
研究者
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