Study to compare the immunogenicity, safety and reactogenicity of SmithKline Beecham’s Twinrix administered following a 2 dose schedule (0, 6 months) to that of Twinrix Junior administered following a 3 dose schedule (0, 1, 6 months) in healthy volunteers aged 12-15 years.

• Conditions: To protect healthy volunteers between the ages of 12 and 15 years against hepatitis A and hepatitis B viruses and to determine the optimal dose range and schedule of the combined hepatitis A / hepatitis B vaccine, with respect to immunogenicity, reactogenicity and safety in this age group.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-001517-27-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-03
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

For primary study:
Healthy male and female volunteers between the ages of 12-15 years at first vaccination will be enrolled in this study.
Negative titres for anti-HAV, anti-HBs, anti-HBc antibodies and / or HBsAg.
Age: between 12 and 15 years at the time of the first vaccination.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Written informed consent obtained from the parent / guardian of the subject.
If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions.
For the LTFU:
Subjects who had received at least one dose of the study vaccine in the primary study HAB-084.
Written informed consent was obtained from each subject or parent/guardian of the subject before the first blood-sampling visit of the follow-up.
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
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 during the study period or within 30 days preceding the first dose of study vaccine.
Administration of chronic immunosuppressants or other immune-modifying drugs within six months.
Planned administration of a vaccine not foreseen by the study protocol during the period starting from one week before each dose of vaccine and ending 30 days after.
Previous vaccination against hepatitis A or hepatitis B.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
Family history of congenital or hereditary immunodeficiency
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Acute disease at the time of enrollment.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Oral or axillary temperature of >= 37.5° C.
Administration of immunoglobulin and / or any blood product within the six months preceding the first dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.

Study & Design

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