Post Market Surveillance for Infanrix™
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.
|Diphtheria Acellular Pertussis Tetanus||Biological: GSK Biologicals' Infanrix™|
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Evaluation of Safety and Efficacy Through Post Market Surveillance for Infanrix™, the DTaP Mixed Vaccine|
- Number of Subjects Reporting Serious Adverse Events [ Time Frame: Since the beginning of the study and during the entire study period (up to 6 years) ]
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.
- Number of Subjects Reporting Solicited Symptoms [ Time Frame: During the 4-week follow-up period after each dose ]
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.
- Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: Within the 31-day (Day 0-30) following vaccination. ]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.
|Study Start Date:||August 2003|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2004 (Final data collection date for primary outcome measure)|
Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
Biological: GSK Biologicals' Infanrix™
Primary and booster vaccination according to vaccination schedule. Intramuscular injection
Other Name: DTPa
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908115
|Korea, Republic of|
|GSK Investigational Site|
|Daegu, Korea, Republic of, 700-712|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|