NCT00211900已完成3 期
A Phase 3, Multicenter, Open-Label, Historical Comparative Study to Evaluate Immunogenicity and Safety of a Commercial Lot of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Type-specific antibody concentrations
研究概览
简要总结
This study answers a U.S. Food and Drug Administration requirement for evaluation in people of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The antibodies in the blood measure the immunogenicity of the vaccine, and typical vaccine safety information is also collected.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8 wk of hemodialysis for ESRD,
- •have written informed consent,
- •a negative serum pregnancy test if appropriate,
- •and expect to comply with protocol procedures and schedule
排除标准
- •known HIV,
- •immunomodulatory drugs,
- •malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer),
- •active infection in the 2 weeks prior to study injection,
- •serious S. aureus infection within the last 3 months prior to injection,
- •use of investigational drugs, vaccines or devices within the prior 30 days,
- •hypersensitivity to components of StaphVAX
结局指标
主要结局
Type-specific antibody concentrations
时间窗: 6 weeks after vaccine dose
次要结局
- Type-specific antibody concentrations(3 weeks after vaccine dose)
- Elicited vaccine reactogenicity.(daily for 7 days after dose)
研究者
研究点 (2)
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