Partially-blind Immunogenicity and Safety Study of GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,659
- 试验地点
- 42
- 主要终点
- Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
研究概览
简要总结
This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •A male or female 18 years of age or older at the time of the first vaccination
- •Subjects who the investigator believes can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject.
- •Healthy subjects or those with chronic well-controlled disease as established by physical examination before entering into 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 urine 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 the vaccination series
排除标准
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of the study vaccine or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- •Administration of an influenza vaccine during the 6 months preceding entry into the study.
- •Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days before vaccination and up to Day
- •Any contra-indication to intramuscular administration of the influenza vaccines.
- •History of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •Any administration of a long-acting immune-modifying drug within 3 months before study start, or planned administration during the study period.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Acute disease and/or fever at the time of enrolment.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- •Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
- •History of chronic alcohol consumption and/or drug abuse.
- •Any condition which, in the opinion of the investigator, prevents the subject from participating in the study
- •Pregnant or lactating female.
研究组 & 干预措施
GSK2321138A Lot 1 Group
Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Influenza vaccine GSK2321138A (Biological)
GSK2321138A Lot 2 Group
Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Influenza vaccine GSK2321138A (Biological)
GSK2321138A Lot 3 Group
Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Influenza vaccine GSK2321138A (Biological)
Fluarix Group
Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
干预措施: FluarixTM (Biological)
GSK2604409A Group
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Influenza vaccine GSK2604409A (Biological)
结局指标
主要结局
Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
时间窗: At Day 0 (D 0), and at Day 21 (D 21)
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease
时间窗: At Day 21 (D 21)
A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer \< 1:10 and a post-vaccination titer above or equal (\>=) 1:40, or a pre-vaccination HI antibody titer \>= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
次要结局
- Number of Days With Solicited Local Symptoms(Within the 7-day (Days 0-6) follow-up period after vaccination)
- Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs)(From the beginning of the study (Day 0) to study end (Day 180))
- Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease(At Day 21 (D 21))
- Number of Seropositive Subjects Against 4 Strains of Influenza Disease(At Day 0 (D 0), and at Day 21 (D 21))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms.(Within the 7-day (Days 0-6) follow-up period after vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(Within the 7-day (Days 0-6) follow-up period after vaccination)
- Number of Days With Solicited General Symptoms(Within the 7-day (Days 0-6) follow-up period after vaccination)
- Number of Subjects With Any and Related Serious Adverse Events (SAEs)(From the beginning of the study (Day 0) to study end (Day 180))
- Number of Seroprotected Subjects Against 4 Strains of Influenza Disease(At Day 0 (D 0), and at Day 21 (D 21))
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within the 21-day (Days 0-20) follow-up period after vaccination)
- Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)(From the beginning of the study (Day 0) to study end (Day 180))