Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2013/2014 in People 18 Years of Age and Above
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains
研究概览
简要总结
The purpose of this study is to assess, in adults 18 years of age and above, the immunogenicity and reactogenicity of the seasonal influenza vaccine, Fluarix/Influsplit SSW 2013/2014, containing the three vaccine influenza strains (two A strains and one B strain) for the 2013/2014 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 can and will comply with the requirements of the protocol.
- •A male or female aged 18 years or above at the time of vaccination.
- •Written informed consent obtained from the subject.
- •Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •has practiced adequate contraception for 30 days prior to vaccination, and
- •has a negative pregnancy test on the day of vaccination, and
- •has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of vaccination.
排除标准
- •Participation in previous year's Fluarix registration study (116663).
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
- •Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
- •Administration of an influenza vaccine within the twelve months preceding the study vaccination.
- •Receipt of a vaccine other than the study vaccine within 30 days before study vaccination and/or plan to receive any vaccine other than the study vaccine during the entire study period.
- •Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
- •Acute disease and/or fever at the time of enrollment.
- •Fever is defined as temperature ≥ 37.5°C/99.5°F on oral, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The preferred route for recording temperature in this study will be axillary.
- •Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
- •Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insulin-dependent diabetes mellitus), not stabilized or clinically serious.
- •History of chronic alcohol consumption and/or drug abuse.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of Guillain-Barré syndrome.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including latex.
- •Anaphylaxis following the administration of vaccine(s).
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •Any condition which, in the opinion of the investigator, prevents the subject from participating in the study or would make intramuscular injection unsafe.
研究组 & 干预措施
Fluarix/Influsplit 18-60 Years Group
Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
干预措施: Fluarix/Influsplit SSW® (2013-2014 season) (Biological)
Fluarix/Influsplit > 60 Years Group
Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
干预措施: Fluarix/Influsplit SSW® (2013-2014 season) (Biological)
结局指标
主要结局
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains
时间窗: At Day 0 and Day 21
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains.
时间窗: At Day 0 and Day 21
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
时间窗: At Day 21
A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
时间窗: At Day 21
MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.
时间窗: At Day 21
SPP was defined as the number of vaccinated subjects with a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
次要结局
- Duration of Solicited Local Symptoms.(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains.(At Day 0 and Day 21)
- Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains(At Days 0 and 21)
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)(During the entire study period (Days 0-180))
- Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.(At Day 21)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.(During the 4-day (Days 0-3) post-vaccination period)
- Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.(At Day 21)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.(During the 4-day (Days 0-3) post-vaccination period)
- Duration of Solicited General Symptoms.(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During the 21-day (Days 0-20) post-vaccination period)