A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate Compared to Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years and Above.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 678
- 试验地点
- 5
- 主要终点
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and the safety of a second vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
详细描述
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •A male or female age 60 years or older at the time of the revaccination, who previously participated in 107192 & 107214 clinical trials.
- •Subjects who the investigator believes can and will comply with the requirements of the protocol
- •Written informed consent obtained from the subject.
- •Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- •Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration 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 up to 30 days after vaccination.
- •History of hypersensitivity to a previous dose of influenza vaccine.
- •History of confirmed influenza infection within the last 12 months.
- •History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- •Acute disease at the time of enrolment.
研究组 & 干预措施
Fluarix Group
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: FluarixTM (Biological)
GSK1247446A Group
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Influenza Vaccine GSK1247446A (Biological)
结局指标
主要结局
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
时间窗: During the 7-day (Days 0-6) post-vaccination period
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
时间窗: During the 7-day (Days 0-6) post-vaccination period
Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering. Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Axillary temperature \> 39.0°C. Related = Symptom considered by the investigator to have a causal relationship to study vaccination.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
时间窗: During the 30-day (Days 0-29) post vaccination period
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 unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
时间窗: During the entire study period (from Day 0 to Day 29)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.
次要结局
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.(At Day 0 and Day 21)
- Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.(At Day 21)
- Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.(At Day 0 and Day 21)
- Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.(At Day 21)