NCT00197184

Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared

Evaluate the Persistence of Immune Response of GSK Biologicals' Twinrix™ Vaccine, Administered According to a 0,6 Month Schedule and a 0,1,6 Month Schedule, in Healthy Children Aged Between 1-11 Years at the Time of First Vaccine Dose

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 3 Years – 13 Years
• Healthy volunteers: Accepted

Summary

To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

Open, randomised, self-contained, multicentric, multinational, long-term antibody persistence studies. Immune persistence was compared between subjects who received either two dose or three doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine. The long-term follow-up studies involved taking blood samples at approximately 2, 3, 4 and 5 years after the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence. No additional subjects will be recruited during the long term follow-up period.

Conditions

• Hepatitis B
• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	Twinrix™ Adult	Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.
BIOLOGICAL	Twinrix™ Junior	Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.

Timeline

• Start date: 2003-11-01
• Primary completion: 2004-03-10
• Completion: 2004-03-10
• First posted: 2005-09-20
• Last updated: 2018-08-20
• Results posted: 2009-06-04

Locations

7 sites across 3 countries: Australia, Belgium, Spain