Post Market Surveillance for Infanrix™

Completed

• Conditions: Tetanus; Acellular Pertussis; Diphtheria
• Interventions: Biological: GSK Biologicals' Infanrix™

• Registration Number: NCT00908115
• Lead Sponsor: GlaxoSmithKline

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 Description

Not available

Study Timeline

• Study Start: 2003-08-01
• Primary Completion: 2008-06-23
• Study Completion: 2008-06-23
• Study First Submitted: 2009-05-21
• Study First Submitted QC: 2009-05-21
• Study First Posted: 2009-05-25
• Results First Submitted: 2009-05-28
• Results First Submitted QC: 2009-05-28
• Results First Posted: 2009-07-17
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1258

Inclusion Criteria

All children receiving Infanrix™ were eligible for this survey.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infanrix Group	GSK Biologicals' Infanrix™	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).

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Serious Adverse Events	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 Unsolicited Adverse Events	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.
Number of Subjects Reporting Solicited Symptoms	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Daegu, Korea, Republic of