Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine
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To evaluate the persistence of immune response 5 years and 6 years after the first vaccine dose.
Condition or disease
Hepatitis BHepatitis A
Biological: Combined Hepatitis A and B vaccine
Open, randomised, long-term antibody persistence studies, conducted in 2 centers. Immune persistence was compared between subjects who received two doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine at either 0, 6 month schedule or 0, 12 month schedule. These long-term follow-up studies involved taking blood samples at approximately 5 and 6 years after the primary vaccination of combined hepatitis A and B vaccine, to assess antibody persistence and a retrospective safety follow-up.
Evaluate the Persistence of Immune Response of GSK Biologicals' TWINRIX™ ADULT, Administered According to 0,6 Month Schedule and 0,12 Month Schedule, in Volunteers Aged 12-15 Years Inclusive at the Time of First Vaccine Dose
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
Immune persistence in terms of anti-HAV and anti-HBs antibodies and GMCs, 5 and 6 years after administration of first vaccine dose. An additional dose of the study vaccine will be given (between 6 to 12 months after the Year 6 time point) to subjects who
Secondary Outcome Measures :
To record the SAEs that was reported since the last time point.
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Layout table for eligibility information
Ages Eligible for Study:
12 Years to 15 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects who received GSK Biologicals' combined hepatitis A and B vaccine in the primary study (HAB-082). Subjects were aged 12 to 15 years at the time of the first vaccination.
Identifier: 100386 (EXT Y5)
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 100386 are summarised with study 100387 on the GSK Clinical Study Register.