This study will evaluate the immunogenicity and safety of Engerix™-B (hepatitis B vaccine) when administered as a primary vaccination course at 0, 1 and 6 months in adults with or without type 2 diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
667
3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
GSK Investigational Site
Huntsville, Alabama, United States
GSK Investigational Site
Number of Subjects Seroprotected for Anti- Hepatitis B Surface Antigen (Anti-HBs) Antibodies
A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL).
Time frame: At one month after the third dose of primary vaccination (Month 7)
Anti-HBs Antibody Concentration
Concentrations were given as geometric mean concentration (GMC) and expressed as mIU/mL
Time frame: At one month after the third dose of primary vaccination (Month 7)
Number of Subjects Reporting Any Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity grade.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any Solicited General Symptoms
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Any fever = oral temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
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Stockbridge, Georgia, United States
GSK Investigational Site
Boise, Idaho, United States
GSK Investigational Site
Mishawaka, Indiana, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Endwell, New York, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
Wenatchee, Washington, United States
...and 12 more locations
Time frame: During the 31-day (Days 0-30) post-vaccination period
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was 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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
Time frame: During the entire study period (Month 0 - Month 7)