NCT01248988已完成不适用
Safety of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal-protein D-diphtheria Toxoid-tetanus Toxoid Conjugate (10PN-PD-DiT) Vaccine, Synflorix 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
- 622
- 试验地点
- 1
- 主要终点
- Occurrence of expected adverse events
研究概览
简要总结
The purpose of this study is to collect safety information following routine vaccination with Synflorix™ among infants in Korea.
详细描述
Rationale for the protocol amendment: The therapeutic indication for Synflorix in Korea has been updated. The protocol is being amended to reflect this update.
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
- 6 Weeks 至 5 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 Representatives can and will comply with the requirements of the protocol.
- •Korean male or female subjects whose age while receiving the first vaccination with Synflorix is 6 weeks - 5 years.
- •Written, signed or thumb-printed 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 a witness.
排除标准
- •At the time of Post Marketing Surveillance entry, the contraindications and precautions of use indicated in the local Prescribing Information should be checked and the infant must not be included in the Post Marketing Surveillance if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.
- •Subjects who receive any investigational or non-registered pneumococcal vaccine 30 days prior to the study start will not be enrolled. Subjects who had previous administration of a pneumococcal vaccine other than Synforix will not be enrolled into the study.
- •A male or female children >= 5 years of age at study entry.
结局指标
主要结局
Occurrence of expected adverse events
时间窗: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.
Occurrence of unexpected 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: From the first dose in the study up to 30 days (Day 0 - Day 29) after the last dose.
次要结局
未报告次要终点
研究者
研究点 (1)
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