NCT00633074已完成2 期
Non-inferiority Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A Using Different Formulations.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 720
- 试验地点
- 3
- 主要终点
- Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
研究概览
简要总结
The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.
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
- 65 Years 至 —（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 65 years of age or older at the time of 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.
排除标准
- •Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, 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 up to 21 days after vaccination.
- •Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- •Previous vaccination against influenza with any seasonal vaccine since July
- •Chronic administration 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.
- •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) including egg and chicken protein.
- •Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed 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.
- •Any medical conditions in which IM injections are contraindicated
研究组 & 干预措施
Thiomersal-free FluAS25 adjuvanted vaccine group
Experimental
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
干预措施: Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A) (Biological)
Thiomersal reduced FluAS25 adjuvanted vaccine group
Experimental
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
干预措施: Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A) (Biological)
结局指标
主要结局
Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
时间窗: Days 0 and 21
Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
次要结局
- Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains(Days 0 and 21)
- HI Antibody Seroconversion Factors(Day 21)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms(During a 7-day period after vaccination)
- Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains(Day 21)
- Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains(Days 0 and 21)
- Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)(During a 21-day period after vaccination)
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)(During the entire study period (up to Day 21))
- Duration of Solicited Local Symptoms(During a 7-day period after vaccination)
- Duration of Solicited General Symptoms(During a 7-day period after vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms(During a 7-day period after vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During a 21-day period after vaccination)
研究者
研究点 (3)
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