A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 5
- 主要终点
- Humoral Immune Response in Terms of Haemagglutination (HA) 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 the immunogenicity and safety of GSK Biologicals' trivalent influenza vaccine manufactured for the 2012/2013 influenza season administered in adults (18 to 60 years) and in elderly (over 60 years).
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.
- •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
- •Use of any investigational or non-registered product 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.
- •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 six months preceding the study vaccination.
- •Planned administration/ administration of a vaccine other than the study vaccine within 30 days before study vaccination and 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 enrolment.
- •Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Chronic underlying disease, 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.
- •History of Guillain-Barré syndrome.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •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.
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 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
干预措施: Fluarix/Influsplit SSW 2012-2013 (Biological)
Fluarix/Influsplit > 60 Years Group
Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
干预措施: Fluarix/Influsplit SSW 2012-2013 (Biological)
结局指标
主要结局
Humoral Immune Response in Terms of Haemagglutination (HA) 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/16/10 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata).
Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
时间窗: At Day 0 and Day 21
Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40.
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 GMT post-vaccination compared to Day 0.
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 vaccinee 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.
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 vaccinees with a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40.
次要结局
- Duration of Solicited Local Symptoms.(During the 4-day follow-up period (Days 0-3) after vaccination)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.(During the 4-day (Day 0-Day 3) follow-up period after vaccination)
- Duration of Solicited General Symptoms.(During the 4-day follow-up period (Days 0-3) after vaccination)
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)(During the entire study period (Days 0-21))
- Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.(At Day 0 and Day 21)
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).(During the 21-day follow-up period (Days 0-20) after vaccination)
- Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.(At Day 0 and Day 21)
- Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.(At Day 21)
- 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, Grade 3 and Related Solicited General Symptoms.(During the 4-day follow-up period (Day 0-3) after vaccination)