At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 883 enrolled
Drug / intervention
FluarixTMbiological
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.
Study to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Influenza Split Vaccine FLUARIX™ Administered According to the Prescribing Information in Korean Subjects Aged More Than 6 Months of Age at the Time of Vaccination
In Brief
A Phase 4 clinical trial evaluating FluarixTM for Influenza. Completed, enrolled 883 participants.
Detailed Summary
The present study collects data on safety and reactogenicity of the vaccine in the local target population (600 or more subjects) as per the requirement of Korean Food and Drugs Administration (KFDA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2003
Primary CompletionDec 2007
Study CompletionDec 2007
First PostedSep 2008
TodayJul 2026
First PostedSep 10, 2008
Enrollment StartOct 3, 2003
Primary CompletionDec 1, 2007
Study CompletionDec 28, 2007
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 17.8 years ago
Interventions
FluarixTMbiological
All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).