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. - ND

MERCK SHARP DOHME0 个研究点目标入组 3,600 人开始时间: 2007年12月17日最近更新: 2019年6月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: MERCK SHARP DOHME
入组人数: 3,600

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

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.Patient is able to understand all study procedures and agrees to participate in the study by providing written informed consent.
•4.Patient intends to participate for the entire study duration (i.e., through postoperative Day 90 for the majority of patients; through postoperative Day 360 for the subset of patients identified to be followed for long-term immune response).
•5.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 cardiothoracic surgery which does not involve a full median sternotomy (i.e., minimally invasive cardiothoracic surgery).
•4.Patient is planning to undergo cardiac transplantation surgery or sternal debridement to remedy an infection resulting from a prior cardiothoracic surgery.
•5.Patient has any type of ventricular-assist device in place at the time of study entry.
•6.Patient has a history of anaphylaxis to any of the vaccine components.
•7.Patient has previously received V710 (in either this study or a previous V710 study).
•8.Patient has received any other investigational S. aureus vaccine or any investigational S. aureus antibodies within the 12 months prior to study entry.
•9.Patient has a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours prior to study vaccination.
•10.Patient has received a 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.
•11.Patient has received any other licensed vaccine (including inactivated or recombinant vaccines) within 14 days prior to receipt of the study vaccine or is scheduled to receive any other licensed vaccine (including non-live virus vaccines) within 30 days postvaccination. (NOTE: Influenza vaccines may be administered during the study, but must be given at least 7 days prior to or at least 15 days after study vaccination).
•12.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.
•13.Patient has received treatment with systemic (intramuscular, oral, or intravenous) corticosteroids (at a prednisone-equivalent dose of ≥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.

研究者

发起方

MERCK SHARP DOHME

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