At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 51 enrolled
Drug / intervention
Twinrix™ adultbiological
Likely dose
Not stated in 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.
Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers
In Brief
A Phase 3 clinical trial evaluating Twinrix™ adult for Hepatitis B and Hepatitis A. Completed, enrolled 51 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 11, 12, 13, 14 and 15 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. This protocol posting deals with objectives \& outcome measures of the extension phase at year 11 to 15.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Hepatitis A
CountriesBelgium
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2004
Primary CompletionMar 2005
First PostedFeb 2006
TodayJul 2026
First PostedFeb 10, 2006
Enrollment StartNov 1, 2004
Primary CompletionMar 2, 2005
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 20.4 years ago
Interventions
Twinrix™ adultbiological
Intramuscular administration