Retrospective Safety Survey of Selected Events in the 6 Months Following the 4th Dose of the Pentacel® Vaccination Series in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,214
- 主要终点
- Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series
研究概览
简要总结
The purpose of this survey is to collect selected safety data.
Primary Objective:
To collect selected safety data at 6 months following the 4th dose of the Pentacel® series.
详细描述
This is a retrospective survey to collect selected safety data at 6 months following the 4th dose of Pentacel® in children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 12 Months 至 24 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday.
- •Written Informed Consent and Telephone consent from the parent(s) or guardian(s).
- •Able to comply with the survey procedures.
排除标准
- •Fourth dose of the Pentacel® series received on or after the child's 2nd birthday.
结局指标
主要结局
Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series
时间窗: 6 months post 4th dose vaccination
Positive response is a 'Yes' to any of the following questions: 1. Has your child been admitted to a hospital? 2. Has your child experienced an illness that made you fear for his/her life (life-threatening episode) that required attendance to the Emergency Room or a Physician's office? 3. Has your child developed a medical condition that required 3 or more office or emergency room visits for that condition? 4. Has your child been diagnosed by a physician as having: Low blood count or low platelet count? Swelling or redness of the joints? Asthma? Diabetes? Autism?
Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine.
时间窗: 6 Months post 4th dose vaccination
SAE: any untoward medical occurrence with the following outcomes: * death, * a life-threatening adverse drug experience (as confirmed by the investigators), * inpatient hospitalization or prolongation of existing hospitalization, * a persistent or significant disability/incapacity, or * a congenital anomaly/birth defect. Medical conditions that required 3 or more office or emergency room visits, and diagnosis by a physician of low blood cell count or low platelet count, swelling or redness of the joints, asthma, diabetes, or autism were also solicited. (MedDRA Version 6.0)
次要结局
未报告次要终点
