Evaluate Immunogenicity & Safety of a Single or Double-dose of the Pandemic Influenza Candidate Vaccine (GSK1562902A) Given Following a Two-administration Schedule (21 Days Apart) in Adults Over 60 Yrs
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 437
- 试验地点
- 13
- 主要终点
- Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.
研究概览
简要总结
The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the pandemic influenza candidate vaccine (GSK1562902A), administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of influenza antibodies will also be evaluated 24 months after vaccination.
详细描述
The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the candidate vaccine in healthy elderly persons. The candidate vaccine will be administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of H5N1 influenza antibodies will also be evaluated up to two years after vaccination (neutralizing antibodies will only be evaluated in a subset of subjects in the adjuvanted groups). Single and double dose of H5N1 vaccine non-adjuvanted vaccine will be used as comparator.
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
- None
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 will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female aged 61 years or above at the time of the first vaccination.
- •Written informed consent obtained from the subject.
- •Healthy subjects or subjects with well controlled underlying disease.
排除标准
- •Administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ during the 2006-2007 influenza season.
- •Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
- •Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of chronic alcohol consumption and/or drug abuse.
- •History of hypersensitivity to vaccines.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (including egg and thiomersal allergy).
- •Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Acute disease at the time of enrolment.
- •Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first vaccination or during the study.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
- •Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
研究组 & 干预措施
GSK1562902A 1 Group
Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
干预措施: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) (Biological)
GSK1562902A 4 Group
Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in the deltoid region of each arm.
干预措施: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) (Biological)
GSK1562902A 1 Group
Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
干预措施: Fluarix (Biological)
GSK1562902A 2 Group
Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
干预措施: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) (Biological)
GSK1562902A 2 Group
Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
干预措施: Fluarix (Biological)
GSK1562902A 3 Group
Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in the deltoid region of each arm.
干预措施: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) (Biological)
GSK1562902A 3 Group
Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in the deltoid region of each arm.
干预措施: Fluarix (Biological)
GSK1562902A 4 Group
Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in the deltoid region of each arm.
干预措施: Fluarix (Biological)
结局指标
主要结局
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.
时间窗: At Day 180
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 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
时间窗: At Month 24
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
时间窗: At Month 24
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 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
时间窗: At Day 180
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
时间窗: At Month 24
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 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
时间窗: At Month 24
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 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
时间窗: At Month 24
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
次要结局
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms.(During the 7-day follow-up period (Days 0 to 6) after any vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (Day 0 to Month 24).)
- Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.(At Days 0, 21 and 42)
- Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells(At Day 180)
- Number of Subjects With Adverse Events of Specific Interest (AESIs)(During the entire study period (Day 0 to Month 24))
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).(During the 21-day (Days 0-20) follow-up period after first vaccination and during the 30-day (Days 0-29) follow-up period after second vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.(During the 7-day follow-up period (Days 0 to 6) after any vaccination)
- Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.(At Days 0, 2, 21 and 23.)