NCT00211991已完成3 期
A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Compare Immunogenicity and Safety Between Three Commercial Lots of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Normal, Healthy, Adult Volunteers
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 354
- 试验地点
- 2
- 主要终点
- Type-specific antibody concentrations 6 weeks after vaccine dose.
研究概览
简要总结
This study answers a U.S. Food and Drug Administration requirement for evaluation in people of the consistency of manufacturing of a vaccine. Subjects are randomized to one of three lots of vaccine. The antibodies in the blood measure the immunogenicity of each lot of vaccine, and typical vaccine safety information is also collected.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •written informed consent,
- •negative serum pregnancy test if appropriate,
- •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 6 weeks after vaccine dose.
次要结局
- Antibody concentrations at other time points.
- Elicited health events.
研究者
研究点 (2)
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