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临床试验/NCT00772369
NCT00772369已完成不适用

Retrospective Safety Survey of Selected Events in the 6 Months Following the 4th Dose of the Pentacel® Vaccination Series in Children

Sanofi Pasteur, a Sanofi Company0 个研究点目标入组 3,214 人开始时间: 2003年9月最近更新:
适应症

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

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

研究者

申办方类型
Industry
责任方
Sponsor

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