Study to evaluate the immunogenicity, safety, and reactogenicity of TWINRIX ADULT containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years.

Conditions: To protect healthy male and female children aged 1 to 11 years old included against hepatitis A and B.
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2015-001516-35-Outside-EU/EEA

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 178

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 < 10 mIU/mL at long-term blood sampling time-points up to Year 10 were eligible to receive a challenge dose of the appropriate vaccine 6 to 12 months after the Year 10 visit.

Are the trial subjects under 18? yes
Number of subjects for this age range: 178
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.