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| Sponsor: | Nabi Biopharmaceuticals |
|---|---|
| Information provided by: | Nabi Biopharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00071214 |
Purpose
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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| 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.
Eligibility| 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:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00071214 History of Changes |
| Other Study ID Numbers: | Nabi-1371 |
| Study First Received: | October 15, 2003 |
| Last Updated: | July 7, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
Staphylococcal infection Gram positive bacteria Staphylococcus Staphylococcus aureus Staphylococcus aureus infection |
|
Kidney Failure, Chronic Renal Insufficiency Staphylococcal Infections Renal Insufficiency, Chronic |
Kidney Diseases Urologic Diseases Gram-Positive Bacterial Infections Bacterial Infections |