Non-Inferiority of GlaxoSmithKline Biologicals' Influenza Vaccine (GSK576389A) 1 Container Over 2 Container Presentation in Adults Aged 65 Years and Over
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,596
- 试验地点
- 7
- 主要终点
- Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain
研究概览
简要总结
This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
The study contains 6 parallel groups, stratified by two age groups: 65-74 years and ≥ 75 years and by two influenza vaccination histories: no influenza vaccination in the last 3 seasons and at least one influenza vaccination in the last 3 seasons.
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
- 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.
- •A male or female aged 65 years or older at the time of the 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
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, 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 2 after vaccination.
- •Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- •Vaccination against influenza since January 2007 (including the Northern Hemisphere NH 2006/2007 or NH 2007/08 influenza vaccine).
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of hypersensivity to a previous dose of influenza vaccine.
- •History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- •Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests.
- •Acute disease at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
- •Any medical conditions in which intramuscular injections are contraindicated.
研究组 & 干预措施
GSK576389A- 2006/2007 Season - 1 container Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
干预措施: GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season] (Biological)
GSK576389A - 2006/2007 Season - 2 containers Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
干预措施: GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season] (Biological)
Fluarix 2006/2007 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
干预措施: Fluarix [NH 2006/07 season] (Biological)
GSK576389A - 2007/2008 Season - 1 container Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
干预措施: GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season] (Biological)
GSK576389A - 2007/2008 Season - 2 containers Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
干预措施: GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season] (Biological)
Fluarix 2007/2008 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
干预措施: Fluarix [NH 2007/08 season] (Biological)
结局指标
主要结局
Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain
时间窗: At Days 0 and 21
Antibody titers were expressed as Geometric mean titers (GMTs). The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens. A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season. A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.
次要结局
- The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations(At Day 21)
- HI Antibody Seroconversion Factors(At Day 21)
- Duration of Solicited Local AEs(During a 7-day follow-up period (Day 0-6) after vaccination)
- HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations(At Days 0 and 21)
- The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations(At Days 0 and 21)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)(During a 7-day follow-up period (Day 0-6) after vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs(During a 7-day follow-up period (Day 0-6) after vaccination)
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)(During a 21-day follow-up period (Day 0-20) after vaccination)
- Duration of Solicited General AEs(During a 7-day follow-up period (Day 0-6) after vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs(During a 21-day follow-up period (Day 0-20) after vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)(During a 21-day follow-up period (Day 0-20) after vaccination)