Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine, Injected According to 0, 6-month Schedule

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Hepatitis A

Treatments: Biological: Havrix™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289757

111030 (Y18) (Other Identifier)

100578 (Y13) (Other Identifier)

111031 (Y19) (Other Identifier)

100580 (Y15) (Other Identifier)

111032 (Y20) (Other Identifier)

100576 (Y11)

100579 (Y14) (Other Identifier)

111029 (Y17) (Other Identifier)

111028 (Y16) (Other Identifier)

100577 (Y12) (Other Identifier)

Details and patient eligibility

About

The aim of this study is to evaluate the long-term persistence of hepatitis A antibodies at 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.

Full description

This is a long-term follow-up study at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To evaluate the long-term antibody persistence, volunteers will donate a blood sample at Years 11, 12, 13, 14,15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary vaccination course to determine their anti-hepatitis A (anti-HAV) antibody concentrations If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point (i.e. Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years), he/ she will be offered an additional vaccine dose. A blood sample will be taken on the day of the additional vaccination, 14 days and one month after additional vaccination to evaluate the immune response following this vaccination.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 and to include an extended follow up period up to Year 20 after primary vaccination.

The study has 10 phases (100576, 100577, 100578, 100579, 100580, 111028, 111029, 111030, 111031, 111032).

Enrollment: 78 patients

Sex: All

Ages: 29 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subjects who had received at least one dose of the study vaccine in the primary study
• Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

78 participants in 1 patient group

Havrix Group

Experimental group

Description:

Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up.

Treatment:

Biological: Havrix™