NCT00938392已完成3 期
Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2186877A in Elderly Adults.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 726
- 试验地点
- 7
- 主要终点
- Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains
研究概览
简要总结
The objective of the study is to evaluate immunogenicity between different formulations of GSK Biologicals' investigational vaccine GSK2186877A.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
- •A man or woman 65 years of age or older at the time of vaccination.
- •Written informed consent obtained from the subject.
- •Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.
排除标准
- •Any confirmed or suspected influenza illness within the last 6 months.
- •Previous vaccination against influenza with any seasonal vaccine since December
- •Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- •Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to Visit
- •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.
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein, included history of hypersensitivity to a previous dose of influenza vaccine.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Acute disease and/or fever at the time of enrolment.
- •Fever is defined as temperature >= 37.5°C on oral setting.
- •Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
- •Any medical conditions in which intramuscular injections are contraindicated.
研究组 & 干预措施
FluNG Aged Group
Experimental
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
干预措施: GSK investigational FluNG vaccine GSK2186877A, aged lot (Biological)
FluNG Fresh Group
Experimental
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
干预措施: GSK investigational FluNG vaccine GSK2186877A, fresh lot (Biological)
结局指标
主要结局
Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains
时间窗: At Days 0 and 21
Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.
次要结局
- Number of Subjects Seroprotected for the 3 Vaccine Strains(At Days 0 and 21)
- Duration of Solicited Local and General Symptoms(During the 7-day post-vaccination period)
- Number of Subjects Reporting Adverse Events of Specific Interest (AESI)(During the 21-day post-vaccination period)
- Number of Subjects Seropositive Against the 3 Vaccine Strains(At Days 0 and 21)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms(During the 7-day post-vaccination period)
- Number of Subjects Seroconverted for the 3 Vaccine Strains(At Day 21)
- Seroconversion Factor for the 3 Vaccine Strains(At Day 21)
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During the 21-day post-vaccination period)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(During the entire study period (up to Day 21))
研究者
研究点 (7)
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