Post-Licensure Safety Surveillance Study of Routine Use of PENTACEL® Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62,538
- 主要终点
- A summary of all non-elective hospitalization and emergency room visits as well as outcome of interest from chart review.
研究概览
简要总结
The objective for this study is to characterize the safety profile of PENTACEL® vaccine for identification of potential vaccine-related adverse events not currently associated with PENTACEL® vaccine administration.
详细描述
The study will be conducted at Kaiser Permanente Northern California and will commence with first use of licensed PENTACEL® vaccine within that organization.
Vaccination databases will be reviewed to identify Diphtheria and tetanus toxoid with acellular pertussis (DTaP) vaccinations of accrued subjects. Medical encounter, emergency room, hospitalization, laboratory, state death reporting, and related databases will be reviewed to identify medical care events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 6 Weeks 至 24 Months（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Receipt of DTaP vaccine during the study period by a previously unvaccinated child
排除标准
- 未提供
结局指标
主要结局
A summary of all non-elective hospitalization and emergency room visits as well as outcome of interest from chart review.
时间窗: Up to 6 months post -dose 4 DTap Vaccination
Outcome of interest identified from Kaiser Permanente Medical Care Program (KPMCP) computerized records via International Classification of Diseases, 9th edition (ICD-9) codes, defined as: * Death, * Outpatient clinic visit for: * seizure occurring within 72 hours of vaccination, Guillain-Barré Syndrome, encephalopathy, encephalitis, alteration of consciousness (other than secondary to another diagnosis), or meningitis * hypersensitivity reactions (e.g. urticaria, angioedema, or anaphylaxis) occurring within 72 hours of vaccination, * new-onset autoimmune disease (including idiopathic thrombocytopenic purpura, hemolytic anemia).
次要结局
未报告次要终点