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临床试验/EUCTR2022-002367-29-BE
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

发起方
Instituut van Tropische Geneeskunde Antwerpen

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