Post Market Surveillance for Infanrix™

Tetanus Clinical Trial

Official title:

Evaluation of Safety and Efficacy Through Post Market Surveillance for Infanrix™, the DTaP Mixed Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908115
• Other study ID #: 208355/128
• Status: Completed
• Start date: August 1, 2003
• Est. completion date: June 23, 2008

Study information

• Verified date: December 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1258
• Est. completion date: June 23, 2008
• Est. primary completion date: June 23, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

All children receiving Infanrix™ were eligible for this survey.

Exclusion Criteria:

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Tetanus

Intervention

Biological:
• GSK Biologicals' Infanrix™
Primary and booster vaccination according to vaccination schedule. Intramuscular injection

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Reporting Serious Adverse Events	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.	Since the beginning of the study and during the entire study period (up to 6 years)
Primary	Number of Subjects Reporting Solicited Symptoms	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.	During the 4-week follow-up period after each dose
Primary	Number of Subjects Reporting Unsolicited Adverse Events	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.	Within the 31-day (Day 0-30) following vaccination.

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.