Post Market Surveillance for Infanrix™
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|ClinicalTrials.gov Identifier: NCT00908115|
Recruitment Status : Completed
First Posted : May 25, 2009
Results First Posted : July 17, 2009
Last Update Posted : October 20, 2016
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.
|Condition or disease||Intervention/treatment|
|Diphtheria Acellular Pertussis Tetanus||Biological: GSK Biologicals' Infanrix™|
|Study Type :||Observational|
|Actual Enrollment :||1258 participants|
|Official Title:||Evaluation of Safety and Efficacy Through Post Market Surveillance for Infanrix™, the DTaP Mixed Vaccine|
|Study Start Date :||August 2003|
|Primary Completion Date :||June 2004|
|Study Completion Date :||June 2008|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908115
|Korea, Republic of|
|GSK Investigational Site|
|Daegu, Korea, Republic of, 700-712|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|