Clinical trial NCT00289744: Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Hepatitis A
Keywords: Hepatitis A
Hepatitis B
TWINRIX™ ADULT
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 178
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
timeFrame: Years 6, 7, 8, 9, and 10.
measure: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
timeFrame: At Year 6, 7, 8, 9 and 10
measure: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
timeFrame: Before and 1 month after the additional dose administration
measure: Number of Subjects With Immune Response to the Additional Dose of Engerix™-B
timeFrame: One month after the additional dose administration
measure: 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
timeFrame: At Year 6, 7, 8, 9 and 10
measure: Number of Subjects Reporting Solicited Local and General Symptoms
timeFrame: During the 4-day follow-up period after additional dose
measure: Number of Subjects Reporting Unsolicited Adverse Events
timeFrame: During the 30-day follow-up period after additional dose
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: During the 30-day follow-up period after additional dose
Secondary outcomes:
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: