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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Hepatitis A

Hepatitis B

Treatments

Biological: Combined Hepatitis A and B vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00197171

100386 (EXT Y5)

100387

Details and patient eligibility

About

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

Full 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.

Enrollment

143 patients

Sex

All

Ages

12 to 15 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Subjects who received GSK Biologicals' combined hepatitis A and B vaccine in the primary study (HAB-082). Subjects were aged 12 to 15 years at the time of the first vaccination.