Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent Vaccine Pregnancy Registry

Completed

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT02148211

Run by

GlaxoSmithKline

People needed

507

Starts

2014-06-01

Expected to finish

2019-05-31

Last updated by the study team

2020-06-12

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• A subject will be included in the Registry if all of the following criteria are met:
• Exposure to GSK sIIVs occurs during pregnancy or within 28 days preceding conception.
• Subject is a US resident.
• A HCP is identified (name, address and phone number).
• Subject can be identified (by GSK or HCP).
• Data from registered subjects will be included in the analyses if the following criterion is met:
• Pregnancy is ongoing and the outcome is unknown at the time of initial report.

You may not qualify if…

• Data from registered subjects will not be included in the analyses if the following criterion is met:
• Outcome of pregnancy is known at the time of initial report. Types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus.

Where it is running

• GSK Investigational Site — Wilmington, North Carolina, United States

Full record on ClinicalTrials.gov

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