EUCTR2009-013344-37-FR进行中（未招募）1 期
Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-Origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Adult and Elderly subjects - Immunogenicity and safety of different formulations of intramuscular swine-origin influenza vaccine
Sanofi Pasteur SA0 个研究点目标入组 450 人开始时间: 2009年7月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
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 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 the first vaccination until at least 4 weeks after the last 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
- •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 Day 42 blood sample
- •7)Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- •8)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)
- •9)Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
- •10)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
- •11)Self-reported thrombocytopenia, contraindicating IM vaccination
- •12)Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- •13)Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •14)Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- •15)Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- •16)Employee 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 of the employees or the Investigator
- •17)Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
- •18)Confirmed infection with the swine-origin A/H1N1 influenza strain (different from the seasonal strain) in 2009
- •19)Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
- •20)Receipt of any allergy shots and/or seasonal allergy medication in the 7-day period prior to enrollment (vaccination), or scheduled to receive any allergy shots and/or seasonal allergy medication in the 7-day period after enrollment (vaccination)
研究者
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