To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course. Subjects were aged 11 to 15 years at the time of the primary vaccination course. At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
All subjects who participated in the primary study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up at Month 42 were contacted by the investigators. No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
267
In the primary study: 2 deep intramuscular injections (Months 0, \& 6)
In the primary study: 3 deep intramuscular injections (months 0, 1 \& 6)
In the primary study: 1 deep intramuscular injection (month 1)
GSK Investigational Site
Sydney, New South Wales, Australia
GSK Investigational Site
Brussels, Belgium
GSK Investigational Site
Wilrijk, Belgium
GSK Investigational Site
Kyiv, Ukraine
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Time frame: At Month 7
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Time frame: At Month 30, Month 42, Month 54 and Month 66
Antibody Titers Against Hepatitis-B Virus.
Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
Time frame: At Month 30, Month 42, Month 54 and Month 66
Antibody Titers Against Hepatitis-B Virus.
Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
Time frame: At Months 1, 2, 6 and 7
Number of Subjects Seroprotected for Anti-HBs Antibody.
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Time frame: At Months 1, 2 and 6
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time frame: During the 4-day (Day 0-3) follow-up period after each vaccination and overall
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) \> 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.
Time frame: During the 4-day (Day 0-3) follow-up period after each vaccination and overall
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE).
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.
Time frame: During the 31-day (Day 0-30) follow-up period after each vaccination and overall
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: During the entire study period (Month 0 to Month 66)
Number of Subjects With Serious Adverse Events (SAEs).
erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: At Month 30, Month 42, Month 54 & Month 66