Trials / Completed
CompletedNCT00572910
A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED)
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of Merck Staphylococcus Aureus Vaccine (V710) in Adult Patients With End-Stage Renal Disease on Chronic Hemodialysis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 206 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a study to evaluate the safety and immunogenicity of V710 with and without Merck Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on hemodialysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Comparator: Placebo (PBO) | Group 6: Placebo (PBO / PBO / PBO) |
| BIOLOGICAL | 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 |
| BIOLOGICAL | V710 Comparator: Placebo (PBO) | Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA Group 4B: V710 (60 mcg / PBO / PBO) with MAA |
| BIOLOGICAL | 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 |
| BIOLOGICAL | V710 Comparator: Placebo (PBO) | Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA Group 2B: V710 (60 mcg / PBO / PBO) without MAA |
| BIOLOGICAL | 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 |
Timeline
- Start date
- 2008-08-01
- Primary completion
- 2010-01-01
- Completion
- 2010-01-01
- First posted
- 2007-12-13
- Last updated
- 2015-04-03
- Results posted
- 2011-08-15
Source: ClinicalTrials.gov record NCT00572910. Inclusion in this directory is not an endorsement.