EUCTR2010-019835-37-FR进行中（未招募）1 期
Safety and Immunogenicity of an Intramuscular H5N1 Inactivated, Split Virion Influenza Vaccine Adjuvanted with AF03 in Adults and Elderly subjects
Sanofi Pasteur SA0 个研究点目标入组 3,200 人开始时间: 2010年5月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,200
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
- •An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
- •1) Aged 18 years or over on the day of inclusion
- •2) Informed Consent Form has been signed and dated
- •3) Able to attend all scheduled visits and to comply with all trial procedures
- •4) For a woman, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination, or having undergone a surgical sterilization or being post-menopausal
- •5) Covered by health insurance or entitled to national social security depending on local regulations
- •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
- •An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
- •1) Known pregnancy, or a positive urine pregnancy test
- •2) Currently breastfeeding a child
- •3) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
- •4) Planned participation in another clinical trial during the present trial period
- •5) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- •6) Planned receipt of any vaccine prior to the blood sample performed 21 days after the second trial vaccination
- •7) Previous vaccination with an H5N1 vaccine
- •8) History of H5N1 infection or exposure to presumed/confirmed (either clinically, serologically, or microbiologically) cases of H5N1-infected humans or animals
- •9) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- •10) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •11) Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
- •12) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- •13) Self-reported thrombocytopenia, contraindicating IM vaccination
- •14) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the opinion of the investigator
- •15) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •16) Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- •17) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •18) Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
- •19) Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
- •20) Receipt of any vaccine with an adjuvant (except for aluminum) in a context of a clinical trial in the past 2 years
- •21) Receipt of an A/H1N1 pandemic influenza vaccine in the context of the national pandemic vaccination campaign 2009-2010
- •22) Known or suspected autoimmune disease or systemic disease (e.g. Sjögren syndrome, lupus erythematosus, rhumatoïde arthritis, sarcoïdosis, vasculitis, etc…)
研究者
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