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 Corp.0 个研究点目标入组 5,700 人开始时间: 2007年12月13日最近更新: 2012年8月28日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Merck Sharp & Dohme Corp.
入组人数: 5,700

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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

排除标准

•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.
•10. Patient is planning to undergo cardiothoracic surgery which does not invlove a full median sternotomy.
•11. Patient has any type of ventricular-assist device in place at the time of study entry.
•12. Patient has a history of anaphylaxis to any of the vaccine components.
•13. Patient has received live virus vaccine within 30 days prior to receipt of the study vaccine or is scheduled to receive any live virus vaccine within 30 days postvaccination.
•14. Patient has received any other licenced vaccine (including inactivated or recombinant vaccines) within 14 days prior to receipt of the study vaccine or is scheduled to receive any other licenced vaccine (including non-live virus vaccines) within 30 days postvaccination.
•15. Patient has received treatment with systemic (intramuscular, oral, or intravenous) corticosteroids (at a prednisone-equivalent dose = 20 mg daily), another immunosuppressive medication (e.g. calcineurin inhibitors, mycophenolate, azathioprine), or biological agents (e.g. rituximab) in the 14 days prior to study vaccination, or is anticipated to receive such medications for a chronic medical condition at any time through postoperative day 90.
•16. Patient has a condition such as haemophilia, other severe coagulation disorders, or significantly impaired venous access, in which repeated venipuncture or injections pose more than minimal risk.
•17. Patient has current evidence or a recent history (within the five years prior to study entry) of intravenous drug abuse.

研究者

发起方

Merck Sharp & Dohme Corp.

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