CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 50 enrolled
Drug / intervention
Twinrix™biological
Likely dose
Twinrix™ intramuscular injection, 3 dosesAI-extracted
Key inclusion· 2
  • ✓Previous enrollment in long-term follow-up studies with documented consent at prior blood sampling timepoints
  • ✓Written informed consent for annual blood sampling visits
Key exclusion· 0

None specified.

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

Search/NCT00289770
NCT00289770Phase 3Completed
CompareCT.gov

A Double Blind Randomised, Comparative Study of the Immunogenicity and Reactogenicity of Three Different Lots of GlaxoSmithKline Biologicals' Combined Hepatitis A - Hepatitis B Vaccine When Administered in Healthy Adults

GlaxoSmithKline·interventional·Posted Feb 10, 2006·Updated Aug 17, 2018

In Brief

A Phase 3 clinical trial evaluating Twinrix™ for Hepatitis B and Hepatitis A. Completed, enrolled 50 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 after subjects received their first dose of a 3 dose primary 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 11-15.

Study Details

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

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 10, 2006
Enrollment StartNov 1, 2004
Primary CompletionDec 20, 2004
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 20.4 years ago

Interventions

Twinrix™biological

Intramuscular injection, 3 doses