The purpose of this study was to investigate the following questions through post-marketing surveillance: * Unknown/Unexpected adverse events and the serious adverse events. * The circumstances in which the adverse events occurred under the practical application. * Factors considered to have influence on safety. * Factors considered to have influence on efficacy. * Miscellaneous - Facts about mechanism, efficacy and safety which were not clearly known due to the inherent problems of the drugs.
Study Type
OBSERVATIONAL
Enrollment
1,258
Primary and booster vaccination according to vaccination schedule. Intramuscular injection
GSK Investigational Site
Daegu, South Korea
Number of Subjects Reporting Serious Adverse Events
A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: Since the beginning of the study and during the entire study period (up to 6 years)
Number of Subjects Reporting Solicited Symptoms
Solicited local symptoms assessed include induration, itching, pain, redness, and swelling. Solicited general symptoms assessed include anorexia, convulsions, cough, diarrhea, drowsiness, eruption, fever, irritability, and vomiting.
Time frame: During the 4-week follow-up period after each dose
Number of Subjects Reporting Unsolicited Adverse Events
An adverse event is 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: Within the 31-day (Day 0-30) following vaccination.
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