EUCTR2009-009877-85-FR进行中（未招募）1 期
Immunogenicity of the Purified Vero Rabies Vaccine – Serum Free in Comparison with the Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adults
Sanofi Pasteur SA0 个研究点目标入组 385 人开始时间: 2009年6月4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
- 385
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 60 years on the day of inclusion
- •2) Provision of a signed Informed Consent Form
- •3) Able to attend all scheduled visits and comply with all trial procedures
- •4) For a woman 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)
- •5) Entitlement 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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test
- •2) Breast-feeding woman
- •3) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- •4) Planned participation in another clinical trial during the present trial period
- •5) 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
- •6) 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
- •7) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
- •8) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
- •9) Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
- •10) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- •11) Planned receipt of any vaccine in the 4 weeks following any trial vaccination
- •12) Known human immunodeficiency virus (HIV), HBs antigen, or Hepatitis C seropositivity
- •13) Previous vaccination against rabies with any vaccine (in pre-or post-exposure regimen)
- •14) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
- •15) Subject at high risk for rabies exposure during the trial period
- •16) Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- •17) Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
- •18) Study site employee who is involved in the protocol and may have direct access to trial-related data
研究者
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