The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
301
Intramuscular injection, 1 dose
Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value
Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)
Time frame: One month after the challenge dose of HBV vaccine
Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value
Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL
Time frame: Before challenge dose of HBV vaccine
Number of Participants Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling
Time frame: During the 4-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants Reporting Solicited General Symptoms
Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache
Time frame: During the 4-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants 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 HBV vaccine.
Number of Participants Reporting Serious Adverse Events (SAE)
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.
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GSK Investigational Site
Birkenfeld, Baden-Wurttemberg, Germany
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, Germany
GSK Investigational Site
Karlsruhe, Baden-Wurttemberg, Germany
GSK Investigational Site
Oberkirch, Baden-Wurttemberg, Germany
GSK Investigational Site
Oberstenfeld, Baden-Wurttemberg, Germany
GSK Investigational Site
Offenburg, Baden-Wurttemberg, Germany
GSK Investigational Site
Pforzheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, Germany
GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, Germany
...and 25 more locations
Time frame: After the challenge dose of HBV vaccine.