Fluarix®/ FluLaval®/ Fluarix® Quadrivalent/ FluLaval® Quadrivalent Vaccine Pregnancy Registry
This trial is active, not recruiting.
|Start date||June 2014|
|End date||June 2019|
|Trial size||1800 participants|
|Trial identifier||NCT02148211, 201476|
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.
Occurrence of abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with Fluarix or FluLaval or Fluarix Quadrivalent or FluLaval Quadrivalent during pregnancy or within 28 days preceding conception.
time frame: Within 3 months of and up to 12 months after the estimated date of delivery (EDD).
Female participants of any age.
Inclusion Criteria: 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. Exclusion Criteria: 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. Pregnancies in which prenatal testing indicates a normal pregnancy would also be excluded because inclusion of such pregnancies could potentially bias results toward a lower overall estimate of risk for defects. Typically pregnancies > 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities.
|Official title||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.|
|Description||This study is a transition of existing ongoing pregnancy registries for Fluarix/ FluLaval/Fluarix Quadrivalent/ FluLaval Quadrivalent into one post-authorization safety study (PASS). Pregnancy outcome data will be collected using questionnaires within 3 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD (for all live births) to ascertain the presence of birth defects not diagnosed before, from Q2 2014 to Q2 2019. The intent of the Registry is to prospectively collect data such as vaccination with GSK sIIVs during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy.|
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