NCT00197171

Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine

Evaluate the Persistence of Immune Response of GSK Biologicals' TWINRIX™ ADULT, Administered According to 0,6 Month Schedule and 0,12 Month Schedule, in Volunteers Aged 12-15 Years Inclusive at the Time of First Vaccine Dose

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Years – 15 Years
• Healthy volunteers: Accepted

Summary

To evaluate the persistence of immune response 5 years and 6 years after the first vaccine dose.

Detailed description

Open, randomised, long-term antibody persistence studies, conducted in 2 centers. Immune persistence was compared between subjects who received two doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine at either 0, 6 month schedule or 0, 12 month schedule. These long-term follow-up studies involved taking blood samples at approximately 5 and 6 years after the primary vaccination of combined hepatitis A and B vaccine, to assess antibody persistence and a retrospective safety follow-up.

Conditions

• Hepatitis B
• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	Combined Hepatitis A and B vaccine

Timeline

• Start date: 2003-09-01
• Primary completion: 2003-12-01
• Completion: 2003-12-01
• First posted: 2005-09-20
• Last updated: 2016-09-07

Locations

2 sites across 1 country: Australia