EUCTR2022-002367-29-BE进行中(未招募)1 期
A two-centre open-label non-inferiority trial to assess the immunogenicity and safety of an intradermal and an intramuscular single-visit dosing regimen of purified chick-embryo cell-culture rabies vaccine in adults - SingleR
Instituut van Tropische Geneeskunde Antwerpen0 个研究点目标入组 360 人开始时间: 2022年8月30日最近更新:
适应症
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
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. =18 to =60 years of age at time of inclusion
- •2. Willingness to provide written informed consent
- •3. Permanent residency in Belgium during the study period
- •4. Prepared to follow the study schedule
- •5. Willing to use contraception during 1 month after each vaccination (only for women of childbearing potential)
- •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 360
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •6. Any vaccination against rabies (memorised or stated in the vaccination certificate)
- •7. Known allergy to one of the components of the vaccines
- •8. Immunocompromised subjects or subjects who take immunosuppressant and/or –stimulant medication
- •9. Planned overseas deployment during the study period
- •10. Ongoing pregnancy or active child wish during the study period (for female subjects)
- •11. Planned vaccination with any inactivated vaccine within 2 weeks before or after each vaccination or with any live attenuated vaccine within 1 month before or after each vaccination
研究者
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