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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8,031
- 主要终点
- Incidence Rate of Vaccine-related Serious Adverse Experiences
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
干预措施: Placebo (Biological)
结局指标
主要结局
Incidence Rate of Vaccine-related Serious Adverse Experiences
时间窗: Up to 360 days after surgery
Vaccine-related adverse experiences were those deemed by the investigator to be possibly, probably, or definitely vaccine related. A serious adverse experience was any adverse experience occurring at any dose that 1) resulted in death, 2) was life threatening, 3) resulted in a persistent or significant disability/incapacity, 4) resulted in or prolonged an existing inpatient hospitalization, 5) was a congenital anomaly/birth defect, 6) was a cancer, 7) was an overdose, or 8) jeopardized the participant and required medical or surgical intervention.
Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection
时间窗: Up to 90 days after surgery
Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the Centers for Disease Control (CDC) Guidelines for Nosocomial infections (Garner JS, Jarvis WS, Emori TG, et al. CDC definitions for nosocomial infections. APIC Infect Control App Epidemiol 1996;A1-20). Bacteremia was defined as ≥1 positive blood culture for S. aureus regardless of the presence of clinical symptoms. A Staphylococcus aureus deep sternal wound infection included mediastinitis or a deep incisional surgical-site infection involving the sternal wound.
次要结局
- Number of Participants With Surgical-site Staphylococcus Aureus Infection(Up to 90 days after surgery)
- Number of Participants With Invasive Staphylococcus Aureus Infection(Up to 90 days after surgery)