CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 178 enrolled
Drug / intervention
TWINRIX™ ADULT +1 morebiological
Likely dose
TWINRIX ADULT 2 doses IM injection (primary study); optional Engerix booster dose if seronegative or seroprotection lostAI-extracted
Key inclusion· 1
  • ✓Prior participation in the primary study with combined hepatitis A/hepatitis B vaccine
Key exclusion· 0

None specified.

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

Search/NCT00289744
NCT00289744Phase 3Completed
CompareCT.gov

Long-Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Children

GlaxoSmithKline·interventional·Posted Feb 10, 2006·Updated Aug 20, 2018

In Brief

A Phase 3 clinical trial evaluating TWINRIX™ ADULT and Engerix TM for Hepatitis B and Hepatitis A. Completed, enrolled 178 participants across 1 site.

Detailed Summary

The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis A/hepatitis B vaccine. This protocol posting deals with objectives \& outcome measures of the extension phase at year 6 through to 10. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Hepatitis A
CountriesBelgium
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 10, 2006
Enrollment StartFeb 16, 2004
Primary CompletionApr 15, 2009
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 20.4 years ago

Interventions

TWINRIX™ ADULTbiological

2 doses IM injection in primary study

Engerix TMbiological

If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.