EUCTR2009-017690-38-FR进行中（未招募）1 期
Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation (Intramuscular Route) - Immunogenicity and Safety of a Vaccine against Influenza (2010-2011 NH season, intramuscular route)
Sanofi Pasteur SA0 个研究点目标入组 129 人开始时间: 2010年3月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 129
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 of childbearing potential, use of an effective method of
- •contraception or abstinence from at least 4 weeks prior to vaccination until at least
- •4 weeks after vaccination
- •5) Entitled to national social security
- •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) Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection
- •(according to investigator judgment) on the day of vaccination
- •2) Known systemic hypersensitivity to eggs, chicken proteins, neomycin,
- •formaldehyde and octoxynol-9, or to any of the vaccine components, or history of
- •a life-threatening reaction to the vaccine used in the trial or to a vaccine
- •containing any of the same substances
- •3) Known pregnancy, or a positive urine pregnancy test
- •4) Currently breastfeeding a child
- •5) History of pandemic H1N1 influenza vaccination
- •6) History of clinically or laboratory confirmed pandemic H1N1 influenza infection
- •7) History of influenza vaccination within the previous 6 months (other than
- •pandemic H1N1 influenza vaccine)
- •8) Receipt of an adjuvanted influenza vaccine in a clinical trial within the previous
- •9) Known or suspected congenital or acquired immunodeficiency, resulting for
- •example from:
- •- End-stage renal disease requiring dialysis
- •- Active neoplastic disease or active hematologic malignancy
- •- Receipt of immunosuppressive therapy or other immune-modifying drugs
- •such as, but not limited to: 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
- •10) History of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B,
- •or Hepatitis C
- •11) Receipt of blood or blood-derived products in the past 3 months, which might
- •interfere with assessment of the immune response
- •12) Chronic illness that, in the opinion of the investigator, is at a stage where it might
- •interfere with trial conduct or completion
- •13) History of thrombocytopenia, contraindicating IM vaccination
- •14) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
- •contraindicating IM vaccination
- •15) Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- •16) Planned receipt of any vaccine in the 3 weeks following the trial vaccination
- •17) Participation in another clinical trial investigating a vaccine, drug, medical device,
- •or medical procedure in the 4 weeks preceding the trial vaccination
- •18) Planned participation in another clinical trial during the present trial period
- •19) Deprived of freedom by an administrative or court order, or in an emergency
- •setting, or hospitalized involuntarily
- •20) Current alcohol abuse or drug addiction that might interfere with the ability to
- •comply with trial procedures
- •21) 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
研究者
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