EUCTR2005-002360-28-BE进行中（未招募）不适用
An open, randomized phase I/II study to demonstrate the non inferiority in term of cellular mediated immune response between GlaxoSmithKline Biologicals influenza candidate vaccines containing various adjuvants administered in elderly population (aged 65 years and older) and Fluarix™ (known as alpha-Rix™ in Belgium) administered in adults (18-40 years) - FLUAS25-003
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 425
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Subjects who the investigator believes they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- •? A male or female aged 18 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 examination before entering into the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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 the vaccine dose, or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, > or equal 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •History of administration of an experimental vaccine containing MPL and/or QS21
- •History of hypersensitivity to a previous dose of influenza vaccine
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, formaldehyde, thiomersal, gentamicin sulfate or sodium deoxycholate.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •History of confirmed influenza infection since a year from the date of previous vaccination
- •Administration of an influenza vaccine in the year 2005
- •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.
研究者
相似试验
进行中（未招募）
1 期
An open, randomized clinical phase I/II trial to investigate maximum tolerated dose, efficacy, and safety of lenalidomide/low-dose dexamethasone in combination with continuous oral cyclophosphamide compared to lenalidomide/low-dose dexamethasone combined with single cyclophosphamide doses IV in patients with relapsed/refractory multiple myelomaEUCTR2008-003829-16-DEGMIHO - Gesellschaft für medizinische Innovation Hämatologie und Onkologie mbH70
进行中（未招募）
不适用
An open, randomized, controlled, phase II study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly as a 3, 5, 12 month vaccination schedule, as part of a staggered vaccination schedule - 11PN-PD-DIT-010EUCTR2004-001823-39-SEGlaxoSmithKline Biologicals150
进行中（未招募）
1 期
Study that tested S64315 plus different standard treatments in patients with breast cancerEUCTR2019-000998-23-ESInstitut de Recherches Internationales Servier
尚未招募
不适用
Evaluate the Efficacy and Safety of Edoxaban in patients with Atrial fibrillation and Mitral stenosisKCT0006484The Catholic University of Korea, Seoul St. Mary's Hospital240
进行中（未招募）
不适用
A phase I/II, open, controlled study in order to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals influenza candidate vaccine containing the adjuvant AS25 (FluAS25) in an elderly population aged over 65 years (>65 years-old) previously vaccinated in 2004 with the same candidate vaccine in FLUAS25-001 clinical trial. For immunogenicity and safety evaluations, Fluarix™ (known as alpha-Rix™ in Belgium)vaccine will be used as reference. - FLUAS25-002EUCTR2005-001928-37-BEGlaxoSmithKline Biologicals100