Assessment of Safety of GlaxoSmithKline (GSK) Biologicals' Combined Reduced Antigen Content Diphtheria-tetanus Toxoids and Acellular Pertussis Vaccine (dTPa), Boostrix When Administered According to the Approved Prescribing Information in Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 682
- 试验地点
- 1
- 主要终点
- Number of Expected AEs.
研究概览
简要总结
The purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea.
详细描述
Protocol amendment 3 rationale was as follows:
- Age for analysis set is specified.
- Subjects with pregnancy will be analyzed by their pregnancy status before/after vaccination.
- Pregnancy notifications must be done within 2 weeks
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written or signed informed consent obtained from the subject/ subject's parent(s)/Legally Acceptable Representative(s) of the child. Korean male or female subjects who were recently vaccinated or eligible to receive Boostrix according to the locally approved Prescribing Information.
排除标准
- •Those who are not eligible for vaccination according to the local Prescribing Information.
- •Child in care.
结局指标
主要结局
Number of Expected AEs.
时间窗: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
Expected AEs were defined as an adverse event that was expected from the subject during the post-vaccination follow-up period as described in the locally approved Prescribing Information in Korea.
Number of Unexpected Adverse Events (AEs)
时间窗: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
Unexpected AEs were defined as adverse events that are not reflected in the approved Prescribing Information in Korea.
Number of Subjects With Serious Adverse Events (SAEs)
时间窗: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
An SAE was defined as any AE that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or that was a congenital anomaly/birth defect in the offspring of a study subject.
次要结局
未报告次要终点