Post-marketing Surveillance Study for the Safety of Hexaxim®, a DTaP-IPV- HB-PRP~T Vaccine Administered to Infants From 2 Months of Age in Republic of Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 713
- 试验地点
- 2
- 主要终点
- Number of participants reporting immediate adverse events/adverse drug reactions (AEs/ADRs)
研究概览
简要总结
Primary objectives:
To investigate the incidence of adverse events occurred following administration of Hexaxim in infants from 2 months of age under routine clinical practice, as per approved indications
详细描述
The duration of each enrolled participant's participation in the study will be up to 36 or 43 days.
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
- 2 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •An infant aged 2 months or more on the day of enrollment
- •Infant whose parent or legal representative has signed and dated the ICF
- •Receipt of 1 dose of Hexaxim on the day of enrollment according to the approved local product label (regardless of vaccinated dose)
排除标准
- •Deviational use (off-label vaccination) from the approval local product label of Hexaxim
- •Previous history of enrollment in this study
- •Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device or medical procedure
研究组 & 干预措施
Cohort
Infants from 2 months of age vaccinated with 1 dose of Hexaxim on the day of enrollment
干预措施: DTaP-IPV-Hep B-PRP-T combined vaccine (Biological)
结局指标
主要结局
Number of participants reporting immediate adverse events/adverse drug reactions (AEs/ADRs)
时间窗: Within 30 minutes post-vaccination
Unsolicited (spontaneously reported) systemic AEs/ADRs
Number of participants reporting serious adverse events / adverse drug reactions (SAEs / SADRs)
时间窗: Up to 43 days post-vaccination
SAEs and SADRs
Number of participants reporting solicited injection site and systemic reactions
时间窗: Up to 7 days post-vaccination
Solicited injection site reactions: tenderness; erythema; site swelling Solicited systemic reactions: vomiting; crying abnormal; drowsiness; appetite loss; irritability
Number of participants reporting unsolicited non-serious AEs/ADRs
时间窗: Up to 28 days post-vaccination
Unsolicited non-serious AEs and ADRs
次要结局
未报告次要终点