NCT00211926已完成3 期
A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine, in Adult Patients Receiving an Orthopaedic Prosthetic Implant
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- serotype-specific antibody concentrations
研究概览
简要总结
S. aureus is the most common pathogen involved in prosthetic joint infection. StaphVAX® is a vaccine to prevent these infections, which conjugates the purified capsular polysaccharides of S. aureus to a carrier protein. It is currently being evaluated for future licensing. This study aims to demonstrate the safety and immunogenicity of a single dose of StaphVAX in patients who are candidates for knee or hip arthroplasty.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •age 18 years or older
- •candidate for knee or hip replacement
- •expectation of protocol compliance
- •negative pregnancy test, where appropriate
排除标准
- •known S. aureus infection in the prior 3 months
- •infection in the prior 2 weeks
- •Known HIV infection
- •immunomodulatory drugs
- •Malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer)
- •Hypersensitivity to components of StaphVAX
结局指标
主要结局
serotype-specific antibody concentrations
时间窗: 6 weeks after dose
次要结局
- serotype-specific antibody concentrations(several other time points after dose, up to 365 days)
- safety: adverse events(0-365 days)
研究者
研究点 (2)
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