EUCTR2005-002401-23-BE进行中（未招募）不适用
Immunogenicity of the Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route in Comparison with Intramuscular Vaccination with Vaxigrip® in Adults.
Sanofi Pasteur SA0 个研究点目标入组 978 人开始时间: 2006年2月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 978
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 57 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 V01
- •5) For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least 4 weeks prior to and at least four weeks after the first vaccination
- •6) Addendum to the informed consent form signed and dated by the subject prior to vaccination at V05
- •7) Addendum to the informed consent form signed and dated by the subject prior to vaccination at V07
- •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 octoxynol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
- •2) Febrile illness (rectal equivalent temperature =38.0°C) on the day of inclusion
- •3) Breast-feeding
- •4) Participation in another clinical trial in the four weeks preceding the first trial vaccination
- •5) Planned participation in another clinical trial during the present trial period
- •6) Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroid therapy
- •7) Chronic illness at a stage that could interfere with trial conduct or completion
- •8) Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures
- •9) Blood or blood-derived products received in the past three months
- •10) Any vaccination in the four weeks preceding the first trial vaccination
- •11) Vaccination planned in the four weeks following the first trial vaccination
- •12) Previous vaccination against influenza (in the previous six months) with the trial vaccine or another vaccine
- •13) Thrombocytopenia or bleeding disorder contraindicating IM vaccination
- •14) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
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