A Study to Demonstrate the Non-Inferiority of Influenza Vaccine Candidate, Compared With Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years Old and Above
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,220
- 试验地点
- 17
- 主要终点
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus
研究概览
简要总结
The purpose of this study is to evaluate the immune response and safety of influenza vaccine candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.
详细描述
Subjects will be randomized into 3 groups and will be followed for 6 months with 4 scheduled contacts per subjects. The immune response will be evaluated at days 0, 21 and 180 after vaccination. The safety evaluation will involve follow-up of solicited local and general signs and symptoms, unsolicited adverse events and serious adverse events.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female age 60 years or older at the time of the vaccination.
- •Subjects who the investigator believes can and will comply with the requirements of the protocol
- •Written informed consent obtained from the subject.
- •Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- •Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration 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 30 days after vaccination.
- •History of hypersensivity to a previous dose of influenza vaccine.
- •Previous vaccination against influenza within the 9 months prior to enrollment.
- •History of confirmed influenza infection within the last 12 months.
- •History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- •Acute disease at the time of enrolment.
研究组 & 干预措施
GSK1247446A-AS03 Group
Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Candidate Influenza Vaccine GSK1247446A - 2 different formulations (Biological)
GSK1247446A Group
Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Candidate Influenza Vaccine GSK1247446A - 2 different formulations (Biological)
Fluarix Group
Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: FluarixTM (Biological)
结局指标
主要结局
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus
时间窗: At Days 0 and 21 post-vaccination
Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.
次要结局
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus(At Day 180 post-vaccination.)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms.(During the 7-day (Days 0-6) follow-up period after vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.(During the 7-day (Days 0-6) follow up period after vaccination)
- Number of Subjects With Unsolicited Adverse Events (AEs).(During the 30-day (Days 0-29) follow-up period after vaccination)
- Number of Subjects With Any and Related Serious Adverse Events (SAEs)(During the entire study period (Day 0 to Day 180))