Study to compare the reactogenicity and evaluate the safety and immunogenicity of GSK Biologicals combined hepatitis A / hepatitis B vaccine administered according to a 0, 6 month schedule versus Twinrix™ Junior administered according to a 0, 1, 6 month schedule in healthy children between 1 to 11 years old.

• Conditions: Therapeutic area: Diseases [C] - Virus Diseases [C02]; Vaccination of healthy children from 1 to 11 years old against Hepatitis

• Registration Number: EUCTR2015-001515-12-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-24
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 511

Inclusion Criteria

Fro the primary study:
A male or female between, and including, 1 and 11 years of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject and/or the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Not known to be seropositive for anti-HAV antibodies, HBs antigen, anti-HBc and anti-HBs antibodies.
Although very unlikely in this age group, female partici-pants who may be at risk of becoming pregnant should take precautions to avoid pregnancy.

For the LTFU:
Subjects who had received at least one dose of the study vaccine in the primary study HAB-120.
Written informed consent was obtained from the parents or guardians of the subject before the blood-sampling visit of each follow-up visit.

Are the trial subjects under 18? yes
Number of subjects for this age range: 511
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

Use of any investigational or non-registered drug or vac-cine other than the study vaccines within 30 days preced-ing the first dose of study vaccine, or planned use during the study period.
Any chronic drug therapy to be continued during the study period.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccines.
Previous vaccination against hepatitis A or B.
History of hepatitis A or B.
Any confirmed or suspected immunosuppressive or im-munodeficient condition, including human immunodefi-ciency virus infection.
History of allergic disease or reactions likely to be exac-erbated by any component of the vaccine.
History of any neurologic disorders or seizures.
Acute disease at the time of enrolment.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified