CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 67 enrolled
Drug / intervention
Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).biological
Likely dose
Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). 0.5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03410953
NCT03410953Phase 4Completed

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

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León·interventional·Posted Jan 25, 2018·Updated Jul 8, 2021

In Brief

A Phase 4 clinical trial evaluating Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). for Hepatitis B and 3 related conditions. Completed, enrolled 67 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJan 25, 2018
Enrollment StartApr 13, 2018
Primary CompletionOct 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.4 years ago

Interventions

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

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