EUCTR2008-000943-33-GB进行中（未招募）不适用
Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)
Sanofi Pasteur SA0 个研究点开始时间: 2008年3月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1) Aged 18 to 60 years (i.e. to the day before the 61st birthday) or 61 years or older (from the day of the 61st birthday) on the day of inclusion
- •2) Provision of a signed informed consent
- •3) Able to attend all scheduled visits and comply with all trial procedures
- •4) For a woman of child-bearing potential: avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 21 days after vaccination
- •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
- •1) For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at V01
- •2) Febrile illness (temperature =37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
- •3) Breast-feeding woman
- •4) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
- •5) Planned participation in another clinical trial during the present trial period
- •6) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- •7) Known systemic hypersensitivity to egg proteins, chick proteins, neomycin, formaldehyde and octoxinol 9, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances
- •8) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
- •9) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
- •10) Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
- •11) Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- •12) Planned receipt of any vaccine in the 3 weeks following the trial vaccination
- •13) Previous vaccination against influenza in the previous 6 months
- •14) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
- •15) Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen or Hepatitis C seropositivity
- •16) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
研究者
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