Post Market Surveillance for Infanrix™

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00908115
First received: May 21, 2009
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Diphteria, Tetanus and Pertussis
Biological: GSK Biologicals' Infanrix™
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Safety and Efficacy Through Post Market Surveillance for Infanrix™, the DTaP Mixed Vaccine

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 1258
Study Start Date: August 2003
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infanrix Group
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All children receiving Infanrix™ were eligible for this survey.

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908115

Locations
Korea, Republic of
GSK Investigational Site
Daegu, Korea, Republic of, 700-712
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00908115     History of Changes
Other Study ID Numbers: 208355/128
Study First Received: May 21, 2009
Results First Received: May 28, 2009
Last Updated: October 13, 2011
Health Authority: Korea: Korea Food & Drug Administration

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections

ClinicalTrials.gov processed this record on April 17, 2014