NCT01568060已完成不适用
Assessment of Safety of GlaxoSmithKline (GSK) Biologicals' Combined Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus Vaccine, Infanrix-IPV When Administered According to the Approved Prescribing Information in Korea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 645
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events
研究概览
简要总结
The purpose of this study is to collect safety information following routine vaccination with Infanrix-IPV among infants and children in Korea.
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 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol.
- •Korean male or female subjects who are eligible for the primary and/or booster doses of Infanrix-IPV according to the Korean Prescribing Information.
- •Written or signed informed consent obtained from the parent(s)/ legally acceptable representative(s) of the child. Where parent(s)/ legally acceptable representatives are illiterate, the consent form will be countersigned by an impartial witness. Prior to enrollment of the subject into the post-marketing surveillance, the subject's parents/legally acceptable representatives will be requested to provide information regarding the enrollment of their child in a same/similar study previously. And prior to obtaining informed consent form, the investigator will check whether the subject is eligible for vaccination.
排除标准
- •At the time of post-marketing surveillance (PMS) entry, the contraindications and precautions of use indicated in the local Prescribing Information should be checked and the subject must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.
- •Subjects who receive any investigational or non-licensed DTPa-IPV vaccine within 30 days prior to study start will not be enrolled.
- •Child in care.
结局指标
主要结局
Occurrence of adverse events
时间窗: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.
Occurrence of serious adverse events
时间窗: Starting at Visit 1 in the post-marketing surveillance (PMS) up to 30 days (Day 0 to Day 29) after the last dose is administered in the PMS
次要结局
未报告次要终点
研究者
研究点 (1)
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