MedTrace Logo

Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines

NCT03410953 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2021-07-08

Study results available
· View outcomes & findings →

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.

Conditions

  • Hepatitis B
  • Hepatitis
  • Hepatitis, Viral, Human
  • Hepatitis B Immunization

Interventions

BIOLOGICAL

Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).

The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine

Sponsors & Collaborators

  • Instituto de Investigación Biomédica de Salamanca

    collaborator OTHER

  • Spanish Clinical Research Network - SCReN

    collaborator NETWORK

  • Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

    lead OTHER

Principal Investigators

  • Jose L. Bravo-Grande, MD PhD · IBSAL-Instituto de Investigación Biomédica de Salamanca

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-13
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03410953 on ClinicalTrials.gov