Flucelvax Pregnancy Registry: an Observational Study on the Safety of Flucelvax Exposure in Pregnant Women and Their Offspring

Seqirus1 site in 1 countrySeptember 2014

ConditionsPregnant Women, Influenza

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pregnant Women, Influenza
Sponsor: Seqirus
Locations: 1
Primary Endpoint: major congenital malformation
Status: Withdrawn
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of the registry is to develop a better understanding of the safety of Flucelvax in women and their offspring who were exposed to the vaccine during pregnancy

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

June 2020

Last Updated

8 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Seqirus

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Pregnancy women pregnant women aged 18 years or older within the US who were immunized with the Flucelvax vaccine at any time during pregnancy.The registry will allow eligible pregnant women to selfenroll and also allow HCPs to report de-identified data on pregnancy exposures and outcomes.
•Sufficient evidence to confirm that Flucelvax exposure occurred during pregnancy
•Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (ie, whether the outcome of pregnancy was known at the time of first contact with the registry)
•Date the pregnancy exposure is registered
•Full reporter (ie, HCP) contact information to allow for follow-up (name, address,etc) The primary population for analysis will include prospectively enrolled pregnancies exposed to Flucelvax that are not lost to follow-up (ie, with outcome information that meet the minimum criteria for evaluation)

Exclusion Criteria

•Invalid registry reports and pregnancies deemed lost to follow-up will be excluded from the primary analysis. Retrospective reports will not be included, although retrospective cases with MCMs will be reviewed and reported separately.