Efficacy, Immunogenicity, and Safety of a Single Dose of V710 in Adult Patients Scheduled for Cardiothoracic Surgery (V710-003 AM2)

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Mediastinitis

Bacteremia

Staphylococcus Aureus

Treatments

Biological: V710

Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00518687

2007_523 (Other Identifier)

V710-003

Details and patient eligibility

About

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.

Enrollment

8,031 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participant is scheduled to undergo cardiothoracic surgery involving a full median sternotomy (not including cardiac transplantation surgery) within 14 to 60 days after vaccination.
Female participants of reproductive potential are required to have a negative urine or serum pregnancy test immediately prior to study vaccination and must use an acceptable form of birth control.

Exclusion criteria

Participants had an invasive Staphylococcus aureus infection within the past 3 months prior to study entry.
A realistic (>50%) possibility that cardiothoracic surgery will be necessary sooner than 10 days after vaccination.
Participant is planning to undergo cardiac transplantation surgery or sternal debridement to remedy an infection resulting from a prior cardiothoracic surgery.
Participant has any type of ventricular-assist device in place at the time of study entry.
Participant has a history of anaphylaxis to any of the vaccine components.
Participant received V710 vaccine, any other investigational Staphylococcus aureus vaccine, or investigational Staphylococcus aureus antibodies.
Participant has a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours prior to study vaccination.
Participant has impairment of the immune system.
Participant has a medical condition in which the expected survival is less than 90 days.