A phase III, open, randomized, multicentre, multicountry study to compare the reactogenicity and evaluate the safety and immunogenicity of GSK Bio’s combined hepatitis A / hepatitis B vaccine (at least 720 EL.U of hepatitis A antigen and 20 µg of hepatitis B surface antigen per dose of 1 ml) administered according to a 0, 6 month schedule by intramuscular injection versus Twinrix™ Junior (at least 360 EL.U of hepatitis A antigen and 10 µg of hepatitis B surface antigen per dose of 0.5 ml) administered according to a 0, 1, 6 month schedule by intramuscular injection in healthy children between 1 to 11 years old. - HAB-120, HAB-132 EXT HAB 120Y2, HAB-133 EXT HAB 120Y3, HAB-134 EXT HAB 120Y4, HAB-137 EXT HAB 120Y5

GlaxoSmithKline Biologicals0 sites511 target enrollmentJune 24, 2015

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Vaccination of healthy children from 1 to 11 years old against Hepatitis
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 511
Status: Active, not recruiting
Last Updated: 10 years ago

No summary available.

Registry

who.int

Start Date

June 24, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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.