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