Long-term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule in Healthy Adults

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Hepatitis A; Hepatitis B

Treatments: Biological: Twinrix™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289770

100553 (EXT Y13) (Other Identifier)

100551 (EXT Y11)

100554 (EXT Y14) (Other Identifier)

100555 (EXT Y15) (Other Identifier)

100552 (EXT Y12) (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 11, 12, 13, 14 and 15 after subjects received their first dose of a 3 dose primary vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

This protocol posting deals with objectives & outcome measures of the extension phase at Year 11-15.

Full description

This is a long-term follow-up study at Years 11, 12, 13, 14 and 15 after primary vaccination with GSK Biologicals' hepatitis A/hepatitis B vaccine (three-dose schedule with 3 different lots). To evaluate the long-term antibody persistence, volunteers will be bled at Years 11, 12, 13, 14 and 15 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.

No additional subjects will be recruited in the course of this extension study. 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 11, 12, 13, 14 or 15), he/ she will be offered an additional vaccine dose.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subjects who had consented to participate in the long-term follow-up studies at the previous long-term blood sampling time points
• Written informed consent will have been obtained from each subject. before the blood sampling visit of each year.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 3 patient groups

Group A

Experimental group

Description:

Was vaccinated with Lot A in the primary study.

Treatment:

Biological: Twinrix™

Group B

Experimental group

Description:

Was vaccinated with Lot B in the primary study.

Treatment:

Biological: Twinrix™

Group C

Experimental group

Description:

Was vaccinated with Lot C in the primary study.

Treatment:

Biological: Twinrix™