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

Phase 3CompletedNCT00197171

GlaxoSmithKline143 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

143

Conditions

Hepatitis B Hepatitis A

Interventions

Combined Hepatitis A and B vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 12 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

GSK Investigational Site

Parramatta, New South Wales, Australia

GSK Investigational Site

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

Immune persistence in terms of anti-HAV and anti-HBs antibodies and GMCs, 5 and 6 years after administration of first vaccine dose. An additional dose of the study vaccine will be given (between 6 to 12 months after the Year 6 time point) to subjects who

Secondary Outcomes

To record the SAEs that was reported since the last time point.

Data from ClinicalTrials.gov

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