Observer Blind Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals Influenza Vaccine GSK576389A Administered to Adults Over 65 Years Previously Vaccinated With the Same Vaccine, Compared to Fluarix™
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,252
- 试验地点
- 30
- 主要终点
- Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
研究概览
简要总结
Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for participation in this study.
详细描述
This study involves 2 age groups (based on primary study):
Subjects enrolled in the >= 65 yrs age group in the primary study. Subjects enrolled in the 18-40 yrs age group in the primary study. The study will be conducted in an open manner for this age group.
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
- Non 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 can and will comply with the requirements of the protocol should be enrolled in the study.
- •Written informed consent obtained from the subject.
- •Free of an acute aggravation of the health status as established by clinical evaluation 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.
- •Male or female subjects who participated in the 104888 study (NCT00377585) and were enrolled in the >= 65 years age group or in the 18-40 years age group .
排除标准
- •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 up to 30 days after vaccination
- •Planned administration of an influenza vaccine other than the study vaccines during the entire study period
- •Any vaccination against influenza since January 2007
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of hypersensitivity to a previous dose of influenza vaccine
- •History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- •Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests
- •Acute disease at the time of enrolment
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
- •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
- •Any medical conditions in which IM injections are contraindicated
- •Pregnant or lactating female, or planning to become pregnant or to discontinue contraceptive precautions.
研究组 & 干预措施
FluAS25 Group
Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
干预措施: GSK Biologicals Influenza Vaccine GSK576389A (Biological)
Fluarix ≥ 65 years age Group
Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
干预措施: Fluarix (Biological)
Fluarix 18-40 years age Group
Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
干预措施: Fluarix (Biological)
结局指标
主要结局
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
时间窗: During a 7-day follow-up period after vaccination
Solicited local AEs assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
Duration of Solicited Local Adverse Events
时间窗: During a 7-day follow-up period after vaccination
Duration was expressed as the median number of days the symptom was experienced.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs)
时间窗: During a 7-day follow-up period after vaccination
Solicited general AEs assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 40°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
Duration of Solicited General Adverse Events
时间窗: During a 7-day follow-up period after vaccination
Duration was expressed as the median number of days the symptom was experienced.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
时间窗: During a 21-day follow-up period after vaccination
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any AE regardless of intensity or relationship to vaccination. Grade 3: AE that prevented normal activity. Related: AE considered by the investigator to be causally related to the study vaccination.
次要结局
- Number of Subjects With Any and Related Serious Adverse Events (SAEs)(During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179))
- Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs)(During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179))
- Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains(At Days 0 and 21)
- Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains(At Day 21)
- Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains(At Day 21)
- Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains(At Days 0 and 21)
- Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers(At Day 0 and 21)
- Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker(At Day 0 and 21)
- Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker(At Day 0 and 21)
- Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker(At Day 0 and 21)
- Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker(At Day 0 and 21)
- Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers(At Day 0 and 21)
- Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker(At Day 0 and 21)
- Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker(At Day 0 and 21)
- Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker(At Day 0 and 21)
- Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker(At Day 0 and 21)