To protect healthy male and female children aged 1 to 11 years old included against hepatitis A and B.
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Persistance phase: Subjects who had received at least one dose of the study vaccine in the primary study HAB-076. Written informed consent was obtained from the subject and/ or parents or guardians of the subject before the blood-sampling visit of each follow-up visit. Challenge dose: Subjects who became seronegative for anti-HAV antibod-ies or had anti-HBs antibody concentrations =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -History of previous vaccination against hepatitis A or B. -History of hepatitis. -History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. -Any acute disease at the moment of entry. -Hepatomegaly, right upper quadrant abdominal pain or tenderness. - Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study. - History of allergic disease likely to be stimulated by any component of the vaccine. - Administration of immunoglobulins within six months of the first vaccination or planned during the study period. -Receipt of any other vaccine within 1 week of a dose of the study vaccine (period extending from 1 week before to 1 week after a dose of vaccine). Simultaneous participation in any other clinical trial, the only exception being involvement in long-term follow-up in another vaccine trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate anti-HAV and anti-HBs antibody persistence at Year 6 (i.e. Month 72), Year 7 (i.e. Month 84), Year 8 (i.e. Month 96), Year 9 (i.e. Month 108) and Year 10 (i.e. Month 120) after the first vaccine dose of two-dose pri-mary vaccination. To evaluate the immune memory (after a primary two-dose schedule of TWINRIX™ ADULT 720/20 vaccine) in subjects who became seronegative for anti-HAV antibod-ies (i.e. titres =10 mIU/mL and GMCs (calculated on the seropositive* subjects) at all LTFU time-points. Safety SAEs that are determined by the investigator to have a causal relationship to primary vaccination, any event related to a lack of vaccine efficacy (i.e. hepatitis A or hepatitis B infection) or SAEs that are related to study participation (blood sampling).;Timepoint(s) of evaluation of this end point: At all LTFU time-points (At Years 6, 7, 8, 9 and 10). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Belgium
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed