EUCTR2006-002369-37-GB进行中（未招募）1 期
ot-to-Lot Consistency Study of the Investigational, Split-virion, Inactivated Influenza Vaccine, Administered by the Intradermal Route in Adults.
Sanofi Pasteur SA0 个研究点目标入组 2,255 人开始时间: 2006年9月20日最近更新:
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
- 2,255
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
入选标准
- •1) Aged 18 to 60 years on the day of inclusion
- •2) Informed consent form signed
- •3) Able to attend all scheduled visits and to comply with all trial procedures
- •4) For a woman, inability to bear a child or negative urine pregnancy test at the first visit (V0)
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components, in particular, neomycin, formaldehyde, and octoxinol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
- •2) Febrile illness (oral temperature = 37.5°C, or rectal equivalent temperature =°38.0°C) on the day of inclusion
- •3) Participation in another clinical trial in the 4 weeks preceding the trial vaccination
- •4) Planned participation in another clinical trial during the present trial period
- •5) 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
- •6) Unstable chronic illness (defined as illness requiring hospitalization or a clinically significant change in medication in the 12 weeks prior to inclusion) at a stage that could interfere with trial conduct or completion
- •7) Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures
- •8) Blood or blood-derived products received in the past 3 months
- •9) Any vaccination in the 4 weeks preceding the trial vaccination
- •10) Vaccination planned in the 4 weeks following the trial vaccination
- •11) Previous vaccination against influenza (in the previous 6 months)
- •12) Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
- •13) 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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ot-to-Lot Consistency Study of the Investigational, Split-virion, Inactivated Influenza Vaccine, Administered by the Intradermal Route in Adults.Vaccination of adults aged 18 to 60 years with inactivated, split-virion influenza vaccine administered by the intradermal route using Vaxigrip® as IM reference vaccine.EUCTR2006-002369-37-LTSanofi Pasteur SA2,250
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