Status:
COMPLETED
Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines
Lead Sponsor:
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Collaborating Sponsors:
Instituto de Investigación Biomédica de Salamanca
Spanish Clinical Research Network - SCReN
Conditions:
Hepatitis B
Hepatitis
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
Health workers with biological risk in their tasks, who have been vaccinated as non-responders to conventional vaccination against Hepatitis B. To provide Health workers-staff with an additional prote...
Detailed Description
An interventional, phase 4, single group assignment, without masking (open label), preventive clinical trial was carried out in health workers with biological risk in their tasks, who have been filed ...
Eligibility Criteria
Inclusion
- NHS workers -including university students doing their internships in health centres dependent on the National Health System (inclusion of students is regulated and limited by specific instructions on labour prevention in each autonomous community).
- 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).
Exclusion
- 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).
- Subjects that have ever had an allergic reaction to any vaccine against hepatitis B.
- Subjects have a serious infection with fever.
- Subjects for whom informed consent is not obtained.
- Subjects that have not revoked the consent initially signed.
Key Trial Info
Start Date :
April 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT03410953
Start Date
April 13 2018
End Date
October 31 2019
Last Update
July 8 2021
Active Locations (11)
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1
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
2
Complejo Asistencial Universitario de León
León, Spain, 24080
3
Hospital Universitario Gregorio Marañón
Madrid, Spain, 28007
4
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034