Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Hepatitis A; Hepatitis B

Treatments: Biological: Engerix TM; Biological: TWINRIX™ ADULT

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289744

100561 (Y6)

100564 (Year 9) (Other Identifier)

100562 (Year 7) (Other Identifier)

100563 (Year 8) (Other Identifier)

100565 (Year 10) (Other Identifier)

Details and patient eligibility

About

The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis A/hepatitis B vaccine.

This protocol posting deals with objectives & outcome measures of the extension phase at year 6 through to 10.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Full description

To evaluate the long-term antibody persistence, volunteers will be bled at Years 6, 7, 8, 9 and 10 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.

If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.

Enrollment: 178 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subjects participating in this study should have participated in the primary study with combined hepatitis A/ hepatitis B vaccine.
• Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood sampling visit of each year.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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178 participants in 3 patient groups

Twinrix Group

Experimental group

Description:

Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix in the primary study (208127/076)

Treatment:

Biological: TWINRIX™ ADULT

Engerix-B Additional Dose (Adult)

Experimental group

Description:

Subjects aged 16 years and above who received an additional dose of EngerixTM-B (adult dose).

Treatment:

Biological: Engerix TM

Engerix-B Additional Dose (Pediatric)

Experimental group

Description:

Subjects under the age of 16 years who received an additional dose of EngerixTM-B (pediatric dose).

Treatment:

Biological: Engerix TM