NCT00406562已完成3 期
Open, Booster Vaccination Study to Assess Safety and Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Administered to Healthy Chinese Children 6-8 Years of Age.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Occurrence of solicited symptoms during 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events
研究概览
简要总结
This study will evaluate the safety and reactogenicity of booster dose of GSK Biologicals' dTpa vaccine (Boostrix) in Chinese children at 6-8 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female between, and including, 6-8 years of age at the time of vaccination,
- •Written informed consent obtained from the parent or guardian of the subject,
- •Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life,
排除标准
- •subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate
- •Subjects with history of diphtheria, pertussis or tetanus diseases can not participate
结局指标
主要结局
Occurrence of solicited symptoms during 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events
次要结局
未报告次要终点
研究者
研究点 (1)
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