VACCINATION ADJUVED AGAINST HEPATITIS B IN SACYL WORKERS TYPED AS NO RESPONDERS TO CONVENTIONAL VACCINES
- Conditions
- Health workers with biological risk in their tasks, who have been vaccinated as non-responders to conventional vaccination against Hepatitis BTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2016-004991-23-ES
- Lead Sponsor
- IBSAL (Instituto de Investigación Biomédica de Salamanca)-Fundación Instituto de Estudios de Ciencias de la Salud de
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 47
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method