In this study, subjects who received primary neonatal vaccination with hepatitis B vaccine at 0, 1, 2, 12 months, 20 years ago in the 103860/272 primary study will be evaluated for immunological memory to hepatitis B vaccine via assessment of the response to a vaccine challenge dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
29
A challenge dose of hepatitis B vaccine will be administered to all subjects as a deep intramuscular injection in the deltoid region of the non-dominant arm.
GSK Investigational Site
Bangkok, Thailand
Number of Subjects With an Immune Response to a Challenge Dose of Hepatitis B Vaccine
Immune response to a challenge dose of hepatitis B vaccine is defined as * at least a 4-fold rise in post-challenge dose anti-HBs antibody concentrations in subjects seropositive (≥ 3.3 mIU/mL) at the previous available long-term time point, or * a post-challenge dose anti-HBs antibody concentrations ≥ 10 mIU/mL in subjects seronegative (\<3.3 mIU/mL) at the previous available long-term time point.
Time frame: One month after the hepatitis B vaccine challenge dose
Number of Subjects With Anti-HBs Antibody Concentrations Above Pre-defined Cut-off Values
Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL.
Time frame: One month after the hepatitis B vaccine challenge dose
Concentration of Anti-HBs Antibodies
Concentrations are given as Geometric Mean Concentrations (GMCs), calculated on subjects seropositive (subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL) post-challenge dose.
Time frame: One month after the hepatitis B vaccine challenge dose
Number of Subjects Reporting Unsolicited Adverse Events
An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: During the 31-day follow-up period after the challenge dose of hepatitis B vaccine
Number of Subjects Reporting Serious Adverse Events
A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
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Time frame: During the 31-day follow-up period after the challenge dose of hepatitis B vaccine