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Post Market Surveillance for Infanrix™

NCT00908115 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1258

Last updated 2020-01-02

Study results available
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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.

Conditions

  • Diphtheria
  • Acellular Pertussis
  • Tetanus

Interventions

BIOLOGICAL

GSK Biologicals' Infanrix™

Primary and booster vaccination according to vaccination schedule. Intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-01
Primary Completion
2008-06-23
Completion
2008-06-23

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00908115 on ClinicalTrials.gov