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StaphVAX in Cardiovascular Surgery Patients

NCT00211913 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2008-01-04

No results posted yet for this study

Summary

S. aureus is the most common pathogen encountered in infection associated with cardiovascular surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides (CPS) that have been implicated as a major factor in the invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus prior to surgery could provide sufficient antibody concentrations during surgery and during the wound healing period so as to decrease the risk of S. aureus infection. This study aims to demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are candidates for cardiovascular surgery.

Conditions

Interventions

BIOLOGICAL

S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

single IM dose totalling 200 mcg of conjugate

BIOLOGICAL

placebo

single IM dose

Sponsors & Collaborators

  • Nabi Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Preston Holley, MD · Nabi Biopharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2005-10-31
Completion
2006-01-31

Countries

  • United States

Study Locations

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Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00211913 on ClinicalTrials.gov