The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 14-15 years who were vaccinated with four doses of Infanrix™-Hexa in the first two years of life and to assess the anamnestic response, immunogenicity, safety and reactogenicity of a single challenge dose of the hepatitis B vaccine Engerix™-B Kinder.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
302
Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 14-15 years of age.
GSK Investigational Site
Kehl, Baden-Wurttemberg, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, Germany
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations
Concentrations were expressed in geometric mean concentrations (GMCs).
Time frame: At Day 30.
Anti-HBs Antibody Concentrations
Concentrations were expressed in geometric mean concentrations (GMCs).
Time frame: At Day 0
Number of Seropositive Subjects for Anti-HBs.
A seropositve subject was defined as a subject with anti-HBs antibody concentrations above the assay cut-off (≥ 6.2 mIU/ml).
Time frame: At Day 0 and Day 30
Number of Seroprotected Subjects for Anti-HBs.
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations equal to or above 10 milli-International units per milliliter (mIU/ml).
Time frame: At Day 0 and day 30
Number of Subjects With Anti-HBs Concentrations Above the Cut-off.
The cut-off of the assay was ≥ 100 mIU/mL.
Time frame: At Day 0 and Day 30
Number of Subjects With an Anamnestic Response to the Hepatitis B Challenge Dose.
Anamnestic response was defined as: For initially seronegative subjects: antibody concentration ≥10mIU/mL. For initially seropositive subjects: antibody concentration at least four times the pre-challenge antibody concentration.
Time frame: At Day 30
Number of Subjects With Any Solicited Local and General Symptoms.
Solicited local symptoms assessed were pain, redness and swelling at injection site. Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (defined as axillary temperature ≥ 37.5°C).
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GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, Germany
GSK Investigational Site
Bindlach, Bavaria, Germany
GSK Investigational Site
Cham, Bavaria, Germany
GSK Investigational Site
Würzburg, Bavaria, Germany
GSK Investigational Site
Goch, North Rhine-Westphalia, Germany
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, Germany
GSK Investigational Site
Wurzen, Saxony, Germany
...and 4 more locations
Time frame: Within 4 days (Day 0 - Day 3) after the vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE was defined as any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Within 31 days (Day 0 - Day 30) after the vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 0 to Day 30