NCT00197119

Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 Years

Evaluate Persistence of Immune Response of GSK Biologicals' TWINRIX™ Vaccine Administered According to 0,6 Month Schedule Versus TWINRIX™ JUNIOR Administered According to 0,1,6 Month Schedule, in Subjects Aged 12-15 Years at Time of First Vaccine Dose

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Years – 15 Years
• Healthy volunteers: Accepted

Summary

To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first dose of the study vaccine.

Detailed description

Open, randomized, long-term antibody persistence studies. Immune persistence was compared between subjects who received one of the two formulations of GlaxoSmithKline Biologicals' combined hepatitis A and hepatitis B vaccine according to a two-dose or three-dose schedule. These long-term follow-up studies involved taking blood samples at approximately 6, 7, 8, 9 and 10 years after the primary vaccination of combined hepatitis A and B vaccine, to assess antibody persistence and a retrospective safety follow-up. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

• Hepatitis B
• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	Twinrix™ Adult	Intramuscular administration in the deltoid region (2 doses).
BIOLOGICAL	Twinrix™ Junior	Intramuscular administration in the deltoid region (3 doses).

Timeline

• Start date: 2004-05-01
• Primary completion: 2004-06-01
• Completion: 2004-06-01
• First posted: 2005-09-20
• Last updated: 2017-04-20
• Results posted: 2009-08-14

Locations

2 sites across 2 countries: Belgium, Czechia