The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 12-13 years who were vaccinated with four doses of Infanrix™-Hexa in infancy 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
301
Single dose administered intramuscularly in deltoid region of non-dominant arm.
GSK Investigational Site
Kehl, Baden-Wurttemberg, Germany
GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, Germany
GSK Investigational Site
Bindlach, Bavaria, Germany
Anti-HBs Immune Response
Anti-HBs immune response was defined as the number of subjects with Anti-HBs antibody concentrations ≥ 100 mIU/ml.
Time frame: One month after the single challenge dose of Engerix-B Kinder vaccine (Month 1)
Anti-HBs Antibody Concentrations at 12-13 Years of Age, After Previous Vaccination With Infanrix Hexa.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 6.2 mIU/ml.
Time frame: Before (PRE) and 1 month after (POST) the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml, ≥ 10 mIU/ml, 10 to < 100 mIU/ml and ≥ 100 mIU/ml.
A seropositive subject was defined as a subject with anti-HBs antibody concentrations ≥ 6.2 milli-international units per milliliter (mIU/ml). A seroprotected subjects was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/ml.
Time frame: Before the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml and ≥ 10 mIU/ml.
A seropositive subject was defined as a subject with anti-HBs antibody concentrations ≥ 6.2 mIU/ml. A seroprotected subjects was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/ml.
Time frame: 1 month after the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With an Anamnestic Response to the Single Challenge Dose of Engerix-B Kinder Vaccine.
The amnestic response to the challenge dose 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.
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GSK Investigational Site
Goch, North Rhine-Westphalia, Germany
GSK Investigational Site
Löhne, North Rhine-Westphalia, Germany
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, Germany
GSK Investigational Site
Leipzig, Saxony, Germany
GSK Investigational Site
Radebeul, Saxony, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany
GSK Investigational Site
Berlin, Germany
...and 1 more locations
Time frame: One month after the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Any Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 4-day (Day 0-3) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Any Solicited General Symptoms.
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature \[defined as axillary temperature equal to oe above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 4-day (Day 0-3) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Any Unsolicited Adverse Events (AEs).
An unsolicited AE covers 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 and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 31-day (Day 0-30) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Serious Adverse Events (SAEs).
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Month 0 to Month 1