The current study will evaluate immunological memory to hepatitis B antigen in subjects who received primary neonatal vaccination of hepatitis B vaccine (Engerix™-B ), 20 years ago in the primary study and who have anti-HBs antibody concentrations \< pre-defined cut-off values at the previous long-term time point. All participating subjects will receive a challenge dose of hepatitis B vaccine. Subjects will be aged approximately 20-21 years at the time of this study. No new subjects will be recruited in this long-term follow-up study. Blood sampling will be done one month after the administration of the challenge dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
76
Intramuscular injection, 1 dose
GSK Investigational Site
Bangkok, Thailand
Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values
The cut-off values assessed include: ≥ 3.3 Milli International Units per Milliliter (mIU/mL), ≥ 10 mIU/mL, and ≥ 100 mIU/mL.
Time frame: One month after the hepatitis B vaccine challenge dose
Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs)
An AE 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. An AE is considered severe if it prevents normal, everyday activities.
Time frame: During the 31-day follow-up period after the challenge dose of hepatitis B vaccine.
Number of Participants Reporting Any Serious Adverse Events (SAEs).
An SAE 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.
Time frame: Up to 1 month after the challenge dose.
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