A Partially Blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal 4-component Investigational Vaccine (GSK2392102A) in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Occurrence of any Serious Adverse events (SAE) in all subjects, in all vaccine groups.
研究概览
简要总结
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of an investigational Staphylococcal 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes can and will comply with the requirements of the protocol.
- •A male or female between 18 and 40 years of age, inclusive, at the time of first vaccination.
- •Written informed consent obtained from the subject.
- •Healthy subjects as established by medical history, clinical examination and laboratory assessment before entering into the study.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •has practiced adequate contraception for 30 days prior to vaccination, and
- •has a negative pregnancy test at Screening, and
- •has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series
排除标准
- •Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
- •Any clinically significant acute or chronic, local or systemic infection, proven or suspected to be caused by Staphylococcus aureus and requiring antibiotic treatment, within the 6 months preceding the first vaccination.
- •Previous administration of any investigational Staphylococcus aureus vaccine/antibodies.
- •History of; or current bleeding or coagulation disorder.
- •Known or suspected reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •History of; or current autoimmune or other immune-mediated disease.
- •Administration or planned administration, of any vaccine not foreseen by the study protocol within 30 days of the first dose of vaccines up to 1 month after the last vaccine dose.
- •Administration of immunoglobulins and/or any blood products within the last 3 months preceding the first dose of study vaccine or planned administration during the study period.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •Any clinically relevant abnormal haematological or biochemical or urine laboratory values at screening.
- •Any acute or chronic, clinically significant disease, as determined by physical examination or laboratory screening tests.
- •Acute disease and/or fever at study entry.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •History of; or current alcoholism and/or drug abuse.
- •Any other condition that the principal investigator judges may interfere with study findings.
研究组 & 干预措施
Group A
干预措施: Staphylococcal investigational vaccine GSK2392103A (Biological)
Group B
干预措施: Staphylococcal investigational vaccine GSK2392105A (Biological)
Group C
干预措施: Staphylococcal investigational vaccine GSK2392106A (Biological)
Group D
干预措施: Staphylococcal investigational vaccine GSK2392019A (Biological)
Group E
干预措施: Saline placebo (Drug)
Group F
干预措施: Saline placebo (Drug)
结局指标
主要结局
Occurrence of any Serious Adverse events (SAE) in all subjects, in all vaccine groups.
时间窗: From first vaccination (Day 0) to study conclusion (Day 540)
Occurrence of any adverse event (AE) of specific interest in all subjects, in all vaccine groups.
时间窗: From first vaccination (Day 0) to study conclusion (Day 540)
Occurrence of solicited local and general adverse events (AEs) in all subjects, in all vaccine groups.
时间窗: During a 7-day (day 0-6) follow up period after each vaccine dose
Occurrence of unsolicited adverse events (AEs) in all subjects, in all vaccine groups.
时间窗: During a 30-day (day 0-29) follow up period after each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
时间窗: 12 months after the last vaccine dose
次要结局
- Immune response to components of the Staphylococcal vaccine formulations in all subjects, in all vaccine groups.(Prior to each vaccine dose, 1, 7 and 29/30 days after each vaccine dose, and 6 and 12 months after the last vaccine dose.)
- Colonisation with Staphylococcus aureus in all subjects, in all vaccine groups.(At Screening (pre-Day 0) and at Days 0, 30, 60, 180, 210 and 540.)