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临床试验/EUCTR2016-004991-23-ES
EUCTR2016-004991-23-ES进行中(未招募)1 期

VACCINATION ADJUVED AGAINST HEPATITIS B IN SACYL WORKERS TYPED AS NO RESPONDERS TO CONVENTIONAL VACCINES

IBSAL (Instituto de Investigación Biomédica de Salamanca)-Fundación Instituto de Estudios de Ciencias de la Salud de0 个研究点目标入组 47 人开始时间: 2017年5月29日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
47

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

入选标准

  • Health workers in the Health Area of ??Salamanca, Zamora, Leon, Valladolid and Palencia
  • Criteria defining them as NO responders to the conventional hepatitis B vaccine: anti HBsAb titers <10 mIU / ml following the application of six doses of conventional vaccine at 20 µg doses (two complete guidelines)
  • 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 47
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Known allergy to the active substance or any of the other ingredients of the medicinal product (included in section 6 of the product data sheet).
  • If you have ever had an allergic reaction to any vaccine against hepatitis B
  • If you have a serious infection with fever.
  • Subjects for whom informed consent is not obtained
  • Subjects that have not revoked the consent initially signed.

研究者

发起方
IBSAL (Instituto de Investigación Biomédica de Salamanca)-Fundación Instituto de Estudios de Ciencias de la Salud de

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