The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 15-16 years who were vaccinated with Engerix™-B Kinder in infancy. The study will also assess the immune response to a challenge dose of Engerix™-B Kinder in these subjects.
This MDD has been updated following the Protocol Amendment 1, dated 20 June 2013. The Protocol was amended because GSK replaced its in-house Enzyme-Linked ImmunoSorbent Assay (ELISA) that was used to measure anti-HBs (antibodies to Hepatitis B surface antigen) antibody concentrations with ChemiLuminescence ImmunoAssay (CLIA). Additionally, the threshold level of prednisone was modified to reflect the dosage normally prescribed to adolescents.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
303
Single dose administered intramuscularly in the deltoid region of non-dominant arm at Day 0.
GSK Investigational Site
Kehl, Baden-Wurttemberg, Germany
GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, Germany
GSK Investigational Site
Bindlach, Bavaria, Germany
GSK Investigational Site
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the 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 Equal to or Above the Cut Off Value.
The cut-off values defined were ≥ 6.2 mIU/mL, ≥ 10 mIU/mL and ≥ 100 mIU/mL.
Time frame: Before (Day 0) and one month after the challenge dose (Month 1)
Antibody Titers Against Hepatitis B Virus
Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% CIs.
Time frame: Before (Day 0) and one month (Month 1) after the challenge dose
Number of Subjects With an Anamnestic Response to the Challenge Dose in Relation to Their Pre Vaccination Status.
Anamnestic response to the challenge dose was defined as: At least (i.e. greater than or equal to ) 4-fold rise in post-vaccination anti-HBs antibody concentrations in subjects seropositive at the pre-vaccination time point Post-vaccination anti-HB antibody concentrations ≥10 mIU/mL in subjects seronegative at the pre-vaccination time point
Time frame: Prior to vaccination with the challenge dose
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. \>50 mm.
Time frame: During the 4-day (Days 0-3) follow-up period after the challenge dose
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Kirchheim, Bavaria, Germany
GSK Investigational Site
Goch, North Rhine-Westphalia, Germany
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, Germany
GSK Investigational Site
Leipzig, Saxony, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany
GSK Investigational Site
Berlin, Germany
GSK Investigational Site
Neumünster, Germany
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever \[axillary temperature above 37.5 degrees Celsius (°C)\]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C
Time frame: During the 4-day (Days 0-3) follow-up period after the challenge dose
Number of Subjects Reporting 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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time frame: During the 31-day (Days 0-30) follow-up period after the challenge dose
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
Serious adverse event was 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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
Time frame: During the entire study period (Day 0 to Month 1)