This phase IV open study will evaluate the persistence of humoral antibodies against hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in adolescents aged 12-13 years, who received three consecutive doses of GSK Biologicals' recombinant hepatitis B vaccine (Engerix™-B) in infancy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
306
Intramuscular, one dose.
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, Germany
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value
The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).
Time frame: One month after the challenge dose (Month 1)
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ChemiLuminescence ImmunoAssay (CLIA) Equal to or Above Cut-off Value.
The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).
Time frame: One month after the challenge dose (Month 1)
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values
The cut-off values were defined as 3.3 mIU/mL, 10 mIU/mL and 100 mIU/mL. Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure.
Time frame: Before (Day 0) and one month (Month 1) after the challenge dose
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values
The cut-off values were defined as 6.2 mIU/mL, 10 mIU/mL and 100 mIU/mL. Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure.
Time frame: Before (Day 0) and one month (Month 1) after the challenge dose
Number of Subjects With Solicited Local and General Symptoms
Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever. Fever was defined as axillary temperature greater than or equal to 37.5 degrees Celsius.
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GSK Investigational Site
Kehl, Baden-Wurttemberg, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Pforzheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, Germany
GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, Germany
GSK Investigational Site
Bindlach, Bavaria, Germany
GSK Investigational Site
Cham, Bavaria, Germany
GSK Investigational Site
Gilching, Bavaria, Germany
...and 14 more locations
Time frame: During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: After the challenge dose of the vaccine (Day 0) up to the study end (Month 1)
Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by ELISA.
Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration equal to or greater than 3.3 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations less than 3.3 mIU/mL) at the pre-challenge dose time point.
Time frame: One month after the challenge dose (Month 1)
Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by CLIA.
Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration ≥ 6.2 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations \< 6.2 mIU/mL) at the pre-challenge dose time point.
Time frame: One month after the challenge dose (Month 1)