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NCT00211913 · ClinicalTrials.gov registry record · Phase 3
StaphVAX in Cardiovascular Surgery Patients
A Phase 3 study, sponsored by Nabi Biopharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
NCT00211913 is a Phase 3 study that has completed, run by Nabi Biopharmaceuticals. The registered enrollment target is 120 participants.
The verdict
NCT00211913, a Phase 3 study, has completed, sponsored by Nabi Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
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.
Interventions
- BIOLOGICAL placebo
- BIOLOGICAL S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2004-06 |
| Est. Completion | 2006-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00211913
The ClinicalTrials.gov registry entry for NCT00211913 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nabi Biopharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00211913 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00211913 about?
NCT00211913 is a clinical study titled "StaphVAX in Cardiovascular Surgery Patients". 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. Immu...
What is the current status of trial NCT00211913?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2004-06. Estimated completion is 2006-01.
What interventions are being tested in trial NCT00211913?
The interventions under investigation include: placebo (BIOLOGICAL), S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate (BIOLOGICAL).
Who is sponsoring clinical trial NCT00211913?
This trial is sponsored by Nabi Biopharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
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