Phase 4
N=67
Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines
Hepatitis B · Hepatitis · Hepatitis, Viral, Human · Hepatitis B Immunization
Bottom Line
View on ClinicalTrials.gov: NCT03410953 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Number of Participants With Protective Levels of Antibodies After Treatment — 63; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Protective Levels of Antibodies After Treatment |
63; 4 | — |
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 protection tool against hepatitis B infection. To evaluate the efficacy of the adjuvanted vaccine in healthy nonresponders to conventional hepatitis B vaccine.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03410953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.