Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
65 participants
INTERVENTIONAL
2005-03-31
2005-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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vaccine
single dose of StaphVAX in hemodialysis patients
S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine
single IM dose totalling 200 mcg of conjugate
Interventions
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S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine
single IM dose totalling 200 mcg of conjugate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* have written informed consent,
* a negative serum pregnancy test if appropriate,
* and expect to comply with protocol procedures and schedule
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Nabi Biopharmaceuticals
INDUSTRY
Responsible Party
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Nabi Biopharmaceuticals
Principal Investigators
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Matt Hohenboken, MD, PhD
Role: STUDY_DIRECTOR
Nabi Biopharmaceuticals
Locations
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Trialogic Research
Madison, Alabama, United States
Countries
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Other Identifiers
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Nabi-1367
Identifier Type: -
Identifier Source: org_study_id
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