Trials / Terminated
TerminatedNCT00518687
Efficacy, Immunogenicity, and Safety of a Single Dose of V710 in Adult Patients Scheduled for Cardiothoracic Surgery (V710-003 AM2)
A Randomized, Multicenter, Double-Blind, Group-Sequential Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine (V710) in Adult Patients Scheduled for Cardiothoracic Surgery
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 8,031 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess the efficacy of a single dose of V710 vaccine to prevent serious Staphylococcus aureus infections following elective cardiothoracic surgery. The study will also evaluate the immune response and general safety of the V710 vaccine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V710 | 0.5-mL single injection of V710 (60 µg) |
| BIOLOGICAL | Placebo | 0.5-mL single injection of matching placebo |
Timeline
- Start date
- 2007-12-01
- Primary completion
- 2011-08-01
- Completion
- 2011-08-01
- First posted
- 2007-08-21
- Last updated
- 2015-10-02
- Results posted
- 2012-11-05
Source: ClinicalTrials.gov record NCT00518687. Inclusion in this directory is not an endorsement.