Observer Blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A With Various Formulations in Adults Aged 65 Years and Above
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2,007
- 试验地点
- 31
- 主要终点
- Haemagglutination Inhibition (HI) Antibody Titers
研究概览
简要总结
In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 65 years and older compared to Fluarix.
详细描述
There are 10 parallel groups: 9 observer blinded groups with subjects 65 years and older receiving an investigational vaccine or Fluarix, and 1 open group with subjects between 18 and 40 years old receiving Fluarix. CMI response will be determined for a subset only.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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
- Double (Participant, Investigator)
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 18-40 years old or 65 years or older at the time of the vaccination.
- •Written informed consent obtained from the subject.
- •Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed 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 (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
- •Administration of other 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 during the entire study period.
- •Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- •Vaccination against influenza since January 2007 (with 2007/2008 or 2006/2007 influenza vaccine).
- •Administration of more than 14 days of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- •Hypersensitivity to a previous dose of influenza vaccine.
- •Allergy to any component of the vaccine.
- •Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
- •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature<37.5ºC (99.5ºF).
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
- •Any medical conditions in which IM injections are contraindicated.
- •Lactating female or female planning to become pregnant or to discontinue contraceptive precautions
研究组 & 干预措施
Influenza vaccine GSK576389A formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
干预措施: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A (Biological)
Influenza vaccine GSK576389A formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
干预措施: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A (Biological)
Influenza vaccine GSK576389A formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
干预措施: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A (Biological)
Influenza vaccine GSK576389A formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
干预措施: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A (Biological)
Influenza vaccine GSK576389A formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
干预措施: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A (Biological)
Influenza vaccine GSK576389A formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
干预措施: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A (Biological)
Influenza vaccine GSK576389A formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
干预措施: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A (Biological)
Influenza vaccine GSK576389A formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
干预措施: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A (Biological)
Fluarix elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
干预措施: Fluarix (Biological)
Fluarix young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
干预措施: Fluarix (Biological)
结局指标
主要结局
Haemagglutination Inhibition (HI) Antibody Titers
时间窗: At Day 21
Antibody titers were expressed as Geometric mean titers (GMTs) against each of the 3 vaccine strains in greater than or equal to 65 years age groups only. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
次要结局
- The Number of Subjects Seroconverted to HI Antibodies at Day 21(At Day 21)
- The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180(At Day 180)
- Duration of Solicited General AEs(During a 7-day follow-up period (Day 0-6) after vaccination)
- HI Antibody Titers at Day 0 and Day 21(At Day 0 and 21)
- HI Antibody Titers at Day 180(At Day 180)
- The Number of Subjects Seroprotected to HI Antibodies at Day 0 and 21(At Day 0 and 21)
- Duration of Solicited Local AEs(During a 7-day follow-up period (Day 0-6) after vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 21 and Day 179(Between Day 21 and Day 179 after vaccination)
- HI Antibody Seroconversion Factors at Day 21(At Day 21)
- HI Antibody Seroconversion Factors at Day 180(At Day 180)
- The Number of Subjects Seroprotected to HI Antibodies at Day 180(At Day 180)
- The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21(At Days 0 and 21)
- The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180(At Day 180)
- The Number of Subjects Seroconverted to HI Antibodies at Day 180(At Day 180)
- The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21(At Days 0 and 21)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)(During a 7-day follow-up period (Day 0-6) after vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs(During a 7-day follow-up period (Day 0-6) after vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs(During a 21-day follow-up period (Day 0-20) after vaccination)
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 and Day 179(Between Day 21 and Day 179 after vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 0 and Day 20(Between Day 0 and Day 20 after vaccination)
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 and Day 20(Between Day 0 and Day 20 after vaccination)