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. - V710 Cardiothoracic Surgery Efficacy, Immunogenicity, and Safety Study

Merck Sharp & Dohme BV0 sites5,700 target enrollmentStarted: November 29, 2007Last updated: June 30, 2019

Trial Snapshot

Phase: Phase 1
Status: Active, not recruiting
Sponsor: Merck Sharp & Dohme BV
Enrollment: 5,700

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

Inclusion Criteria

•1.Patient is 18 years of age or greater.
•2.Patient is scheduled to undergo cardiothoracic surgery involving a full median sternotomy (not including cardiac transplantation surgery) within 14 to 60 days postvaccination.
•3.Female patients of reproductive potential are required to have a negative urine or serum pregnancy test immediately prior to study vaccination. Female patients of reproductive potential must have been using an acceptable form of birth control for two weeks prior to enrollment, and agree to use an acceptable method of birth control for one month postvaccination. Acceptable methods of birth control include use of hormonal contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, tubal ligation, condoms, or abstinence.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•1.Patient developed an invasive S. aureus infection (e.g., bacteremia, endocarditis, pneumonia, mediastinitis, osteomyelitis, etc.) in the three months prior to study entry.
•2.Patient’s underlying condition is sufficiently unstable so that there is a realistic (>50%) possibility that cardiothoracic surgery will be necessary within the 10 days following study entry/vaccination.
•3.Patient is planning to undergo cardiac transplantation surgery or sternal debridement to remedy an infection resulting from a prior cardiothoracic surgery.
•4.Patient has received any other investigational S. aureus vaccine or any investigational S. aureus antibodies within the 12 months prior to study entry.
•5.Patient has a temperature of =100.4ºF (=38.0ºC), oral equivalent, within 48 hours prior to study vaccination.
•6.Patient was administered any immunoglobulin within 90 days prior to study vaccination or is scheduled to receive such products at any time through postoperative Day 90.
•7.Patient has a known or suspected impairment of immunologic function including, but not limited to, the following conditions: autoimmune disease, moderate/severe hepatic insufficiency or cirrhosis, renal failure or insufficiency (on hemodialysis or peritoneal dialysis), immunoglobulin deficiency, or other congenital or acquired immunodeficiency, including HIV/AIDS.
•8.Patient is currently pregnant or breastfeeding, or planning to conceive at any time throughout the duration of the study (through postoperative Day 90).
•9.Patient has a medical condition in which the expected survival is less than 90 days.

Investigators

Sponsor

Merck Sharp & Dohme BV

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