Influenza Clinical Trial
Official title:
FluLaval® Quadrivalent Pregnancy Registry: a Prospective, Exploratory, Cohort Study to Detect and Describe Any Abnormal Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With FluLaval® Quadrivalent During Pregnancy or Within 28 Days Preceding Conception
The purpose of this pregnancy registry study is to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent. The Registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (HCPs). Data such as vaccination with FluLaval Quadrivalent 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 will be collected prospectively.
Some pregnancy exposures may be reported after pregnancy outcome has been identified
(retrospective reports). The Registry will capture retrospective reports, but these reports
will not be included in the analyses of prospective reports.
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 from
30 November 2013 to 31 May 2018.
;
Observational Model: Cohort, Time Perspective: Prospective
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