CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,258 enrolled
Drug / intervention
GSK Biologicals' Infanrix™biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00908115
NCT00908115N/ACompleted
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Evaluation of Safety and Efficacy Through Post Market Surveillance for Infanrix™, the DTaP Mixed Vaccine

GlaxoSmithKline·observational·Posted May 25, 2009·Updated Jan 2, 2020

In Brief

An observational study evaluating GSK Biologicals' Infanrix™ for Diphtheria and 2 related conditions. Completed, enrolled 1,258 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Acellular Pertussis, Tetanus
CountriesSouth Korea
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 25, 2009
Enrollment StartAug 1, 2003
Primary CompletionJun 23, 2008
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 17.1 years ago

Interventions

GSK Biologicals' Infanrix™biological

Primary and booster vaccination according to vaccination schedule. Intramuscular injection