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临床试验/NCT00130260
NCT00130260终止3 期

Phase 3b Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating Immunogenicity and Safety of a 3rd and 4th Dose of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults With End-Stage Renal Disease

Nabi Biopharmaceuticals1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2005年8月最近更新:
适应症

试验速览

阶段
3 期
状态
终止
入组人数
99
试验地点
1
主要终点
serotype-specific antibody concentrations

研究概览

简要总结

This study is a continued evaluation of the immune response to StaphVAX , a Staphylococcus aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease patients, by giving a 3rd and 4th dose to a subset of the participants in the previous efficacy trial. Participants continue to receive the vaccine or placebo in a blinded manner, and are also randomly assigned to 1 of 2 different intervals between the doses. The immunogenicity is measured by the antibodies in the blood, 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
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

入选标准

  • Participation in prior study Nabi-1371
  • Written informed consent
  • Negative serum pregnancy test, where 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 2 months prior to injection
  • Hypersensitivity to components of StaphVAX

结局指标

主要结局

serotype-specific antibody concentrations

时间窗: 6 weeks after each dose

次要结局

  • serotype-specific antibody concentrations(at several other time points up to 12 months after dose)
  • elicited vaccine reactogenicity(daily for 7 days after each dose)

研究者

申办方类型
Industry

研究点 (1)

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