At a glance
ClinicalIndex Comparison RecordN/ACompleted· 507 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.
Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent Pregnancy Registry: a Prospective, Exploratory, Cohort Study to Detect and Describe Abnormal Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Fluarix or Fluarix Quadrivalent or FluLaval or FluLaval Quadrivalent During Pregnancy or Within 28 Days Preceding Conception.
In Brief
An observational study evaluating Data collection for Influenza. Completed, enrolled 507 participants across 1 site.
Detailed Summary
The purpose of this pregnancy registry study is to detect and describe abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with any of GlaxoSmithKline (GSK) Biologicals' seasonal Inactivated Influenza Vaccines (sIIVs): Fluarix, FluLaval, Fluarix Quadrivalent and FluLaval Quadrivalent.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartJun 2014
Primary CompletionMay 2019
TodayJul 2026
First PostedMay 28, 2014
Enrollment StartJun 1, 2014
Primary CompletionMay 31, 2019
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 12.1 years ago
Interventions
Data collectionother
Initial and follow-up data was collected using questionnaires.