A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED)
NCT ID: NCT00572910
Last Updated: 2015-04-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
206 participants
INTERVENTIONAL
2008-08-31
2010-01-31
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
DOUBLE
Study Groups
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V710 - Group 1
V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
V710 Comparator: Placebo (PBO)
Group 1A: V710 (60 mcg / 60 mcg / 60 mcg) without MAA
Group 1B: V710 (60 mcg / 60 mcg / PBO) without MAA
V710 - Group 2
V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
V710 Comparator: Placebo (PBO)
Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA
Group 2B: V710 (60 mcg / PBO / PBO) without MAA
V710 - Group 3
V710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
V710 Comparator: Placebo (PBO)
Group 3A: V710 (60 mcg / 60 mcg / 60 mcg) with MAA
Group 3B: V710 (60 mcg / 60 mcg / PBO) with MAA
V710 - Group 4
V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
V710 Comparator: Placebo (PBO)
Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA
Group 4B: V710 (60 mcg / PBO / PBO) with MAA
V710 - Group 5
V710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
V710 Comparator: Placebo (PBO)
Group 5A: V710 (90 mcg / 90 mcg / 90 mcg) with MAA
Group 5B: V710 (90 mcg / 90 mcg / PBO) with MAA
Group 6
Placebo on Day 1, 28 and 180.
Comparator: Placebo (PBO)
Group 6: Placebo (PBO / PBO / PBO)
Interventions
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Comparator: Placebo (PBO)
Group 6: Placebo (PBO / PBO / PBO)
V710 Comparator: Placebo (PBO)
Group 5A: V710 (90 mcg / 90 mcg / 90 mcg) with MAA
Group 5B: V710 (90 mcg / 90 mcg / PBO) with MAA
V710 Comparator: Placebo (PBO)
Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA
Group 4B: V710 (60 mcg / PBO / PBO) with MAA
V710 Comparator: Placebo (PBO)
Group 3A: V710 (60 mcg / 60 mcg / 60 mcg) with MAA
Group 3B: V710 (60 mcg / 60 mcg / PBO) with MAA
V710 Comparator: Placebo (PBO)
Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA
Group 2B: V710 (60 mcg / PBO / PBO) without MAA
V710 Comparator: Placebo (PBO)
Group 1A: V710 (60 mcg / 60 mcg / 60 mcg) without MAA
Group 1B: V710 (60 mcg / 60 mcg / PBO) without MAA
Eligibility Criteria
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Inclusion Criteria
* Female patients who are able to have children must have a negative urine pregnancy tests
Exclusion Criteria
* Has been vaccinated with a live virus within the past 30 days or are scheduled to be vaccinated with a live virus in the next 60 days
* Received V710 vaccine before
18 Years
80 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Moustafa M, Aronoff GR, Chandran C, Hartzel JS, Smugar SS, Galphin CM, Mailloux LU, Brown E, Dinubile MJ, Kartsonis NA, Guris D. Phase IIa study of the immunogenicity and safety of the novel Staphylococcus aureus vaccine V710 in adults with end-stage renal disease receiving hemodialysis. Clin Vaccine Immunol. 2012 Sep;19(9):1509-16. doi: 10.1128/CVI.00034-12. Epub 2012 Jul 25.
Other Identifiers
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2007_609
Identifier Type: -
Identifier Source: secondary_id
V710-005
Identifier Type: -
Identifier Source: org_study_id
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