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Sponsored by: |
Nabi Biopharmaceuticals |
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Information provided by: | Nabi Biopharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00071214 |
Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic hemodialysis patients against infection by Staphylococcus aureus.
Condition | Intervention | Phase |
---|---|---|
Staphylococcal Infections Kidney Failure, Chronic |
Biological: S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Efficacy of StaphVAX, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis |
Estimated Enrollment: | 3600 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | September 2005 |
Two part clinical trial designed to evaluate the efficacy of StaphVAX in adults on hemodialysis. Part A will evaluate the prevention of bacteremic infections in End Stage Renal Disease (ESRD) patients during the interval between 3 and 35 weeks after a single dose of StaphVAX. Part B of this study is designed to assess immunogenicity of a second [booster] dose of vaccine in patients completing Part A, and the cumulative (Part A + B) efficacy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Eligible subjects must already be receiving chronic hemodialysis treatment from the centers participating in this study. Interested subjects should discuss enrollment with their nephrologist.
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | Nabi-1371 |
Study First Received: | October 15, 2003 |
Last Updated: | July 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00071214 |
Health Authority: | United States: Food and Drug Administration |
Staphylococcal infection Gram positive bacteria Staphylococcus Staphylococcus aureus Staphylococcus aureus infection |
Bacterial Infections Staphylococcal Infections Gram-Positive Bacterial Infections Renal Insufficiency Urologic Diseases |
Renal Insufficiency, Chronic Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Infection |