NCT00363870已完成4 期
A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine (Fluarix™) Administered Intramuscularly in Adults
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7,632
- 试验地点
- 16
- 主要终点
- occurrence of confirmed influenza
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of GSK Biologicals' influenza vaccine (Fluarix™) administered intramuscularly in adults.
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
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female age between 18 and 64 years at the time of the first vaccination.
- •non-childbearing female
排除标准
- •Use of non-registered products
- •Pregnancy
- •Hypersensitivity to a previous dose of influenza vaccine
- •Acute disease at the time of enrolment/vaccination.
- •History of allergy or reactions likely to be exacerbated by any component of the vaccine
- •Administration of any other influenza vaccine for the season 2006-2007
- •Chronic disorders of the pulmonary or cardiovascular system, including asthma.
- •Administration of immune-modifying drugs
- •Administration of immunoglobulins and/or any blood products
- •History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, asthma or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus)
结局指标
主要结局
occurrence of confirmed influenza
次要结局
- Occurrence of pneumonia
- Safety during 7 Months
- occurrence of influenza like illness
- Immune response at days 0 and 21
研究者
研究点 (16)
Loading locations...
相似试验
已完成
3 期
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in ChildrenInfluenzaNCT01198756GlaxoSmithKline3,109
已完成
3 期
A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in ChildrenInfluenzaNCT01218308GlaxoSmithKline5,220
已完成
2 期
Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of AgeInfluenzaNCT01974895GlaxoSmithKline316
已完成
1 期
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.InfluenzaNCT00714285GlaxoSmithKline420
已完成
2 期
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in AdultsInfluenzaNCT00951041GlaxoSmithKline130