An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine (GSK3003891A) in Healthy Men
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Occurrence of each solicited local and general adverse event (AE)
研究概览
简要总结
The purpose of this first time in human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of Respiratory Syncytial Virus (RSV) investigational vaccines in healthy men.
详细描述
This protocol posting has been updated following protocol amendment 3 to amend the respective exclusion criterion as to only exclude subjects with clinically significant hematological/ biochemical abnormalities as per opinion of the investigator.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject.
- •A male between, and including, 18 and 44 years of age at the time of vaccination.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
排除标准
- •Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before or after vaccination.
- •Previous vaccination against RSV.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the vaccine dose. Inhaled and topical steroids are allowed.
- •Administration of long-acting immune-modifying drugs at any time during the study period.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Family history of congenital or hereditary immunodeficiency.
- •History of or current autoimmune disease.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •Hypersensitivity to latex.
- •Any clinically significant hematological (hemoglobin level, white blood cell [WBC], lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine) abnormality as per the opinion of the investigator, based on the local laboratory normal ranges.
- •Subjects with hematological/ biochemical values out of normal range which are expected to be temporary may be re-screened at a later date.
- •Any acute or chronic, clinically significant disease, as determined by physical examination or laboratory screening tests.
- •Malignancies within previous 5 years (excluding non-melanoma skin cancer) and lymphoproliferative disorders.
- •Current alcoholism and/or drug abuse.
- •Acute disease and/or fever at the time of Screening.
- •Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on rectal route. The preferred route for recording temperature in this study will be oral.
- •Subjects with a minor illness (such as mild diarrhea) without fever may be enrolled at the discretion of the investigator.
- •Subjects with acute disease and/ or fever at the time of Screening may be re screened at a later date.
- •Planned move to a location that will prohibit participating in the trial until study end.
- •Any other condition that the investigator judges may interfere with study procedures (e.g. drawing blood) or findings (e.g. immune response).
研究组 & 干预措施
Group A
Subjects in this group will receive a single dose of formulation 1 of RSV vaccine
干预措施: RSV vaccine GSK3003892A (formulation 1) (Biological)
Group B
Subjects in this group will receive a single dose of formulation 2 of RSV vaccine
干预措施: RSV vaccine GSK3003893A (formulation 2) (Biological)
Group C
Subjects in this group will receive a single dose of formulation 3 of RSV vaccine
干预措施: RSV vaccine GSK3003895A (formulation 3) (Biological)
Group D
Subjects in this group will receive a single dose of formulation 4 of RSV vaccine
干预措施: RSV vaccine GSK3003896A (formulation 4) (Biological)
Group E
Subjects in this group will receive a single dose of formulation 5 of RSV vaccine
干预措施: RSV vaccine GSK3003898A (formulation 5) (Biological)
Group F
Subjects in this group will receive a single dose of formulation 6 of RSV vaccine
干预措施: RSV vaccine GSK3003899A (formulation 6) (Biological)
Group Placebo 1
Subjects in this group will receive a single dose of placebo
干预措施: Placebo comparator (Drug)
Group Placebo 2
Subjects in this group will receive a single dose of placebo
干预措施: Placebo comparator (Drug)
结局指标
主要结局
Occurrence of each solicited local and general adverse event (AE)
时间窗: During the 7 days (Days 0-6) follow-up period after vaccination
Occurrence of any Serious Adverse Events (SAEs)
时间窗: From Day 0 to Day 60
Occurrence of any hematological (hemoglobin level, white blood cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality
时间窗: At Day 30
Occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality
时间窗: At Day 60
Occurrence of any unsolicited AE
时间窗: During a 30-day (Days 0-29) follow-up period after vaccination
次要结局
- Occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (ALT, AST and creatinine) laboratory abnormality(At Day 180 and Day 360)
- Occurrence of any SAE(From Day 60 to the study conclusion (i.e. Day 360))
- Humoral immune response in terms of neutralizing antibody titers to the investigational RSV vaccines, in all subjects, in all groups(At pre-vaccination (Day 0) and post-vaccination (Day 7, Day 30 and Day 60))
- Persistence of the humoral immune response in terms of neutralizing antibody titers to the investigational RSV vaccines, in all subjects, in all groups(At Day 180 and Day 360)