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OpenTrials
Completed

NCT Number: NCT00908115

Post Market Surveillance for Infanrix™

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.

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Key information

Conditions

Diphtheria Acellular Pertussis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Corynebacterium Infections Gram-Positive Bacterial Infections Infections Tetanus

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Daegu, 700-712, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All children receiving Infanrix™ were eligible for this survey.

Exclusion criteria

Treatment and study plan

GSK Biologicals' Infanrix™

Biological

Primary and booster vaccination according to vaccination schedule. Intramuscular injection

Other names: DTPa

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
May 25, 2009
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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