A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in People Aged 18 Years or Above
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 6
- 主要终点
- Number of Seroconverted Subjects
研究概览
简要总结
This study is designed to test the immunogenicity and reactogenicity of the FluarixTM/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2009-2010 season.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 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 will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female aged 18 years or above at the time of the vaccination.
- •Written informed consent obtained from the subject.
- •Healthy subjects or with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study.
- •If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
排除标准
- •Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
- •Administration of an influenza vaccine within 6 months preceding the study start.
- •Administration of an influenza vaccine other than the study vaccine during the entire study
- •Clinically or virologically confirmed influenza infection within 6 months preceding the study start
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Acute disease at the time of enrolment.
- •Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Not stabilized or clinically serious chronic underlying disease.
- •Lactating female.
- •History of chronic alcohol consumption and/or drug abuse.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
研究组 & 干预措施
Fluarix Adult Group
Subjects who are 18-60 years of age received one dose of Fluarix™
干预措施: Fluarix™/Influsplit SSW® (Biological)
Fluarix Elderly Group
Subjects who are > 60 years of age received one dose of Fluarix™
干预措施: Fluarix™/Influsplit SSW® (Biological)
结局指标
主要结局
Number of Seroconverted Subjects
时间窗: Day 21
A seroconverted subject is a subject with a pre-vaccination serum HI titer \< 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4
Seroconversion Factor
时间窗: Day 21
Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains
Seroprotection Power
时间窗: Day 21
Seroprotection power is defined as the number of subject who had a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40
Hemagglutination Inhibition (HI) Antibody Titer
时间窗: Day 0 and Day 21
Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains
Number of Subjects With HI Antibody Titer Above the Cut-off Value
时间窗: Day 0 and Day 21
The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains
Number of Seroprotected Subjects
时间窗: Day 0 and Day 21
A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40
次要结局
- Number of Subjects Reporting Solicited Local Symptoms(During the 4-day (Day 0-3) post-vaccination period)
- Number of Subjects Reporting Solicited General Symptoms(During the 4-day (Day 0-3) post-vaccination period)
- Number of Subjects Reporting Unsolicited Adverse Events (AE)(During the 21-day (Day 0-20) post-vaccination period)
- Number of Subjects Reporting Serious Adverse Events (SAE)(During the entire study period)