A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of Adjuvanted Influenza Vaccine Candidate Compared to Fluarix™ (GlaxoSmithKline Biologicals) Administered Intramuscularly in Elderly Aged 60 Years and Older.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
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
- •Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.
- •A male or female 60 years or older at the time of the first vaccination.
- •Free of obvious health problems
排除标准
- •Use of non-registered products
- •Administration of immune-modifying drugs.
- •Administration of vaccine 30 days before enrolment in study.
- •Immunosuppressive or immunodeficient condition.
- •Hypersensitivity to a previous dose of influenza vaccine
- •Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
- •History of confirmed influenza infection within the last 12 Months.
- •Acute disease at the time of enrolment/vaccination.
- •History of allergy or reactions likely to be exacerbated by any component of the vaccine
研究组 & 干预措施
GSK1247446A Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
干预措施: GSK1247446A Group (Biological)
Fluarix Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
干预措施: Fluarix™ (Biological)
结局指标
主要结局
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
时间窗: At Days 0 and 21
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
时间窗: At Day 21
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
时间窗: At Day 21
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
时间窗: At Day 0 and Day 21
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
次要结局
- Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.(At Days 0 and 21)
- Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.(At Days 0 and 21)
- Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.(During the 7-day (Days 0-6) post-vaccination period)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.(During the 7-day (Days 0-6) post-vaccination period)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).(During the 30-day (Days 0-29) post vaccination period)
- Number of Subjects With Any and Related Serious Adverse Events (SAEs).(During the entire study period (from Day 0 to Day 29))