NCT00289744

Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Accepted

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.

Detailed description

To evaluate the long-term antibody persistence, volunteers will be bled at Years 6, 7, 8, 9 and 10 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations. 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.

Conditions

• Hepatitis B
• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	TWINRIX™ ADULT	2 doses IM injection in primary study
BIOLOGICAL	Engerix TM	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.

Timeline

• Start date: 2004-02-16
• Primary completion: 2009-04-15
• Completion: 2009-04-15
• First posted: 2006-02-10
• Last updated: 2018-08-20
• Results posted: 2010-08-26

Locations

1 site across 1 country: Belgium