EUCTR2015-005194-20-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free in Comparison with the Reference Purified Vero Rabies Vaccine in Post-exposure Use in Healthy Subjects in China
Sanofi Pasteur SA0 个研究点目标入组 816 人开始时间: 2015年11月17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
- 816
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
- •Subjects aged = 18 years
- •1)Aged = 18 years 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
- •Subjects aged 10 to 17 years
- •5)Aged 10 to 17 years on the day of inclusion
- •6)Informed Consent Form has been signed and dated by the parent(s) or another legally acceptable representative and by subjects aged 12 years and over. In addition, provision of assent form signed by subjects aged 10 to 11 years
- •7)Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
- •8)For a female of childbearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 408
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 408
- •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 medical procedure in the 4 weeks preceding the first trial vaccination
- •2)Planned participation in another clinical trial during the present trial period
- •3)Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- •4)Planned receipt of any vaccine during the course of the trial
- •5)Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine
- •6)Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- •7)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)
- •8)Self-reported seropositivity for Human Immunodeficiency Virus (HIV), or Hepatitis C, or reported by the parent/guardian
- •9)At high risk for rabies infection during the trial (such as veterinarians and their staff, animal handlers, rabies researchers, and certain laboratory workers, persons whose activities bring them into frequent contact with rabies virus or potentially rabid bats, raccoons, skunks, cats, dogs, or other species at risk for having rabies, people travelling where rabies is enzootic, previous Category 2 or 3 bite within the year before trial participation by a suspected rabid animal with no post-exposure treatment administered)
- •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 intramuscular vaccination, or reported by the parent/guardian
- •12)Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular 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)Known pregnancy, or a positive urine pregnancy test
- •17)Currently breastfeeding a child
- •18)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.
研究者
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