Evaluation of Safety and Efficacy Through Post Market Surveillance for Infanrix™, the DTaP Mixed Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,258
- 试验地点
- 1
- 主要终点
- Number of Subjects Reporting Serious Adverse Events
研究概览
简要总结
The purpose of this study was to investigate the following questions through post-marketing surveillance:
- Unknown/Unexpected adverse events and the serious adverse events.
- The circumstances in which the adverse events occurred under the practical application.
- Factors considered to have influence on safety.
- Factors considered to have influence on efficacy.
- Miscellaneous - Facts about mechanism, efficacy and safety which were not clearly known due to the inherent problems of the drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children receiving Infanrix™ were eligible for this survey.
排除标准
- 未提供
结局指标
主要结局
Number of Subjects Reporting Serious Adverse Events
时间窗: Since the beginning of the study and during the entire study period (up to 6 years)
A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Number of Subjects Reporting Unsolicited Adverse Events
时间窗: Within the 31-day (Day 0-30) following vaccination.
An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Number of Subjects Reporting Solicited Symptoms
时间窗: During the 4-week follow-up period after each dose
Solicited local symptoms assessed include induration, itching, pain, redness, and swelling. Solicited general symptoms assessed include anorexia, convulsions, cough, diarrhea, drowsiness, eruption, fever, irritability, and vomiting.
次要结局
未报告次要终点