NCT00109330已完成3 期
A Phase III, Observer-blinded Randomised, Multi-centre Clinical Study of the Safety, Immunogenicity and Consistency of Three Manufacturing Lots of GSK Biologicals' Candidate Tdap Vaccine as Compared to a US-licensed Td Vaccine When Given as a Booster Dose to Healthy Adolescents (10-18 Years of Age)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,116
- 试验地点
- 45
研究概览
简要总结
This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of age).
详细描述
A combined Tdap (Tetanus, Diphteria, Acellular Pertussis) Vaccine Used as a Booster compared to Licensed Td (Tetanus and Diphteria) vaccine
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adolescents with history of completed routine vaccination against diphtheria, tetanus, and pertussis (DTP).
排除标准
- •Use of any other investigational drug or vaccine 30 days preceding study vaccination.
- •Chronic administration of immunosuppressants.
- •Administration of pre-school DTP vaccine within previous 5 years.
- •Administration of Td booster within previous 10 years.
研究者
研究点 (45)
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