Clinical Trial: Post Market Surveillance for Infanrix™
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Evaluation of Safety and Efficacy Through Post Market Surveillance for Infanrix™, the DTaP Mixed Vaccine
Brief Summary:
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.
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome:
- 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.
Original Primary Outcome:
- Occurrence of Serious Adverse Events [ Time Frame: Throughout the study ]
- Occurrence of solicited local symptoms and general symptoms [ Time Frame: During the 4-week follow-up period after each dose ]
- Occurrence of unsolicited symptoms [ Time Frame: During the 4-week follow-up period after each dose ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: GlaxoSmithKline
Dates:
Date Received: May 21, 2009
Date Started: August 2003
Date Completion:
Last Updated: September 16, 2016
Last Verified: September 2016