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
120 participants
INTERVENTIONAL
2004-06-30
2006-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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vaccine
single dose of StaphVAX®
S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
single IM dose totalling 200 mcg of conjugate
placebo
single dose
placebo
single IM dose
Interventions
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S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
single IM dose totalling 200 mcg of conjugate
placebo
single IM dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Expected to comply with protocol
* Negative pregnancy test where appropriate
* Written informed consent
Exclusion Criteria
* Known infection in the past 2 weeks
* Known HIV infection
* Pregnancy or breast-feeding
* Immunomodulatory drugs
* Malignancy or treatment for malignancy within the past six months, other than basal cell, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or early stage prostate cancer
* investigational drugs, vaccines or products in the past 30 days
* Hypersensitivity to components of StaphVAX
18 Years
ALL
Yes
Sponsors
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Nabi Biopharmaceuticals
INDUSTRY
Responsible Party
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Nai Biopharmaceuticals
Principal Investigators
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Preston Holley, MD
Role: STUDY_DIRECTOR
Nabi Biopharmaceuticals
Locations
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Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Countries
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Other Identifiers
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Nabi-1366
Identifier Type: -
Identifier Source: org_study_id
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