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

Condition(s) targeted: Hepatitis B; Hepatitis A

Intervention: TWINRIX™ ADULT (Biological); Engerix TM (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: Long-Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Children

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration

Number of Subjects With Immune Response to the Additional Dose of Engerix™-B

Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy

Number of Subjects Reporting Solicited Local and General Symptoms

Number of Subjects Reporting Unsolicited Adverse Events

Number of Subjects Reporting Serious Adverse Events (SAEs)

Detailed 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.

Minimum age: 7 Years. Maximum age: 17 Years. Gender(s): Both.

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.

GSK Investigational Site, Wilrijk 2610, Belgium

Starting date: February 2004
Last updated: October 2, 2014