NCT00336115Unknown4 期
Safety and Immunogenicity of Adult Formulation Tetanus and Diphtheria Toxoids Adsorbed Combined With Acellular Pertussis (Tdap) Vaccine Following Blood and Morrow Transplantation in Adults
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 10
- 主要终点
- Safety of the vaccine
研究概览
简要总结
The purpose of this study is to determine if pertussis (whooping cough) vaccine is safe and produces an appropriate immune response against pertussis in blood and marrow transplant patients.
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
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-64
- •BMT at the QEII Health Sciences Centre
- •BMT within last 12 months
- •Able to read and write English language
- •Able to give consent
排除标准
- •Active infection
- •Active GVHD
- •Recent IVIG
- •Allergy to components of vaccine
- •Diphtheria or tetanus vaccination within 18 months
结局指标
主要结局
Safety of the vaccine
时间窗: 28 days post-dose
次要结局
- Immunogenicity of vaccine(60 days post-dose)
研究者
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