Exposure to quadrivalent influenza vaccine during pregnancy: Results from a global pregnancy registry.

ABSTRACT:

Background

The Fluzone® Quadrivalent (IIV4, Sanofi Pasteur) Pregnancy Registry was created to monitor vaccine safety during pregnancy (clinicaltrials.gov, NCT01945424). Here, we describe maternal, pregnancy, obstetrical and neonatal outcomes after vaccine exposure in pregnant women between August 2013 and September 2019.

Methods

All women exposed to IIV4 during their pregnancy were eligible for inclusion. Outcomes were prospective (reported following vaccine exposure but before knowledge of pregnancy outcome ascertained through prenatal tests) or retrospective (prenatal tests were undertaken before the exposure was reported).

Results

Among 239 IIV4 vaccine exposure reports received, there were 105 prospective and 10 retrospective reports of maternal adverse events (AE

SUBMITTER: Ledlie S 

PROVIDER: S-EPMC8692812 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature