At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,388 enrolled
Drug / intervention
Data collectionother
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.
Assessment of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information in Korea.
In Brief
An observational study evaluating Data collection for Influenza, Human. Completed, enrolled 1,388 participants across 21 sites.
Detailed Summary
The purpose of this study is to collect safety information on the use of Fluarix Tetra according to the approved PI, in Korea, over a period of 6 years from children greater than or equal to (≥)3 years of age and adults, and over a period of 4 years from children between 6 months and 35 months of age.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human
CountriesSouth Korea
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartOct 2016
Primary CompletionFeb 2021
TodayJul 2026
First PostedJan 26, 2016
Enrollment StartOct 20, 2016
Primary CompletionFeb 5, 2021
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 10.4 years ago
Interventions
Data collectionother
Safety monitoring and evaluation: - Recording of all AEs during the study period using diary cards, follow-up contact via telephone or email. - Recording of SAEs throughout the study period for each subject.