EUCTR2008-005791-27-FI进行中（未招募）不适用
Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in European Children
Sanofi Pasteur SA0 个研究点开始时间: 2009年1月12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
- •All Subjects:
- •1) Subject and parent(s)/legal representative able to attend all scheduled visits and to comply with all trial procedures
- •2) Completion of vaccination according to the national immunization schedule
- •Subjects Aged =2 Years to <18 Years:
- •3) Aged =2 years to <18 years on the day of inclusion.
- •4) Provision of Informed Consent Form signed by the subject's the parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 8 to 11 years, and of Informed Consent Form signed by subjects =12 years.
- •5) For a female of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination.
- •Subjects Aged =6 Months to <2 Years:
- •6) Aged =6 months to <2 years on the day of inclusion.
- •7) Born at full term of pregnancy (=37 weeks) with a birth weight =2.5 kg.
- •8) Provision of Informed Consent Form signed by the parent(s) or other legal representative (and by an independent witness if required by local regulations).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •All subjects:
- •1) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding trial vaccination
- •2) Planned participation in another clinical trial during the present trial period
- •3) 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
- •4) Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- •5) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
- •6) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
- •7) Receipt of Blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
- •8) Receipt of any vaccine in the 4 weeks preceding trial vaccination
- •9) Planned receipt of any vaccine in the 4 weeks following any trial vaccination
- •10) (Known) Human Immunodeficiency Virus (HIV), HBs antigen or Hepatitis C seropositivity
- •11) Previous vaccination against avian influenza with either the trial vaccine or another vaccine
- •12) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
- •13) Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- •14) Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
- •Subjects Aged =2 Years to <18 Years:
- •15) For a female of child-bearing potential, known pregnancy or positive urine pregnancy test
- •16) Breast-feeding female
- •17) Febrile illness (temperature =37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
- •Subjects Aged =6 Months to <2 Years:
- •18) History of seizures
- •19) Febrile illness (temperature =38°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
研究者
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