Long-Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Children
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 178
- Locations
- 1
- Primary Endpoint
- Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Exclusion Criteria
- Not provided
Arms & Interventions
Twinrix Group
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix in the primary study (208127/076)
Intervention: TWINRIX™ ADULT (Biological)
Engerix-B Additional Dose (Adult)
Subjects aged 16 years and above who received an additional dose of EngerixTM-B (adult dose).
Intervention: Engerix TM (Biological)
Engerix-B Additional Dose (Pediatric)
Subjects under the age of 16 years who received an additional dose of EngerixTM-B (pediatric dose).
Intervention: Engerix TM (Biological)
Outcomes
Primary Outcomes
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Time Frame: Years 6, 7, 8, 9, and 10.
Number of Subjects With Immune Response to the Additional Dose of Engerix™-B
Time Frame: One month after the additional dose administration
Immune response was defined as: * anti-hepatitis B surface antigen (anti-HBs) antibody concentration equal or above to 10 milli-international units per milliliter (mIU/mL) at 1 month post-challenge dose in subjects seronegative at the pre-challenge time-points * at least a 4-fold increase in anti-HBs antibody concentrations at 1 month post-challenge dose in subjects seropositive at the pre-challenge time-points.
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Time Frame: Before and 1 month after the additional dose administration
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
Time Frame: At Year 6, 7, 8, 9 and 10
Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects Reporting Solicited Local and General Symptoms
Time Frame: During the 4-day follow-up period after additional dose
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.
Number of Subjects Reporting Unsolicited Adverse Events
Time Frame: During the 30-day follow-up period after additional dose
Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time Frame: During the 30-day follow-up period after additional dose
Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Time Frame: At Year 6, 7, 8, 9 and 10
Secondary Outcomes
No secondary outcomes reported