StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery
NCT ID: NCT00211965
Last Updated: 2008-01-04
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
67 participants
INTERVENTIONAL
2005-04-30
2006-08-31
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
S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate
single IM dose of 200 mcg total conjugate
placebo
single dose
placebo
single dose IM
Interventions
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S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate
single IM dose of 200 mcg total conjugate
placebo
single dose IM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Candidate for knee or hip replacement
* Expectation of protocol compliance
* Negative pregnancy test, where appropriate
Exclusion Criteria
* 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 prostate cancer)
* Hypersensitivity to components of StaphVAX
18 Years
ALL
Yes
Sponsors
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Public Health England
OTHER_GOV
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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National Royal Orthopaedic Hospital
Stanmore, Middlesex, United Kingdom
Countries
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Other Identifiers
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Nabi-1363
Identifier Type: -
Identifier Source: org_study_id
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