A Study of Staphylococcus Aureus Vaccine (V710) in Patients Scheduled for Cardiothoracic Surgery


Tracking Information

Start Date  ICMJEDecember 2007
Estimated Primary Completion DateJune 2013   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: December 17, 2007)		Prevention of serious S. aureus infections for 90 days following cardiothoracic surgery; all adverse experiences for 14 days after vaccination. [ Time Frame: 90 days following cardiothoracic surgery; 14 days after vaccination ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00518687 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: December 17, 2007)		Invasive S. aureus infection for 90 days following cardiothoracic surgery; S. aureus surgical-site infections for 90 days following cardiothoracic surgery. [ Time Frame: 90 days following cardiothoracic surgery ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of Staphylococcus Aureus Vaccine (V710) in Patients Scheduled for Cardiothoracic Surgery
Official Title  ICMJEA Randomized, Multicenter, Double-Blind, Group-Sequential Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Single Dose of Merck Staphylococcus Aureus Vaccine (V710) in Adult Patients Scheduled for Cardiothoracic Surgery
Brief Summary

This study is being performed to assess the efficacy of a single dose of V710 vaccine to prevent serious S. aureus infections following elective cardiothoracic surgery. The study will also evaluate the immune response and general safety of the V710 vaccine.

Detailed Description 
Study PhasePhase II, Phase III
Study Type  ICMJEInterventional
Study Design  ICMJEPrevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Staphylococcus Aureus
  • Bacteremia
  • Mediastinitis
Intervention  ICMJE
  • Biological: V710
    V710 single 0.5 ml injection
  • Biological: Comparator: Placebo (unspecified)
    single 0.5 ml Pbo injection
Study Arms / Comparison Groups
  • 1: Experimental
    Arm 1: vaccine
    Intervention: Biological: V710
  • 2: Placebo Comparator
    Arm 2: Pbo Comparator
    Intervention: Biological: Comparator: Placebo (unspecified)

Recruitment Information

Estimated Enrollment  ICMJE8044
Estimated Completion DateJanuary 2014
Estimated Primary Completion DateJune 2013   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age or greater
  • Scheduled for cardiothoracic surgery involving a full median sternotomy within 14 to 60 days after vaccination
  • Female patients are required to have a negative urine or blood pregnancy test immediately prior to study vaccination and must use an acceptable form of birth control

Exclusion Criteria:

  • An invasive S. aureus infection within the past 3 months
  • A realistic (>50%) possibility that cardiothoracic surgery will be necessary sooner than 10 days after vaccination
  • Cardiac transplantation surgery or sternal debridement to remedy an infection resulting from an earlier cardiothoracic surgery
  • Presence of a device to help pump blood through the heart (Ventricular assist devices (VAD))
  • Received V710 vaccine, any other investigational S. aureus vaccine, or investigational S. aureus antibodies
  • Temperature of equal/greater than 100.4 degrees F(38 degrees C) within the past 48 hours
  • Impairment of the immune system
  • A medical condition for which the expected survival is less than 90 days
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Toll Free Number1-888-577-8839
Location Countries  ICMJEUnited States,   Belgium,   Brazil,   Finland,   France,   Germany,   Guatemala,   Italy,   Japan,   Korea, Republic of,   Mexico,   Norway,   Peru,   Russian Federation,   Spain,   Sweden,   Taiwan,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00518687
Responsible PartyExecutive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Study ID Numbers  ICMJE2007_523, V710-003
Study Sponsor  ICMJEMerck
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Medical MonitorMerck
Information Provided ByMerck