Afluria Pregnancy Registry

Seqirus

Status: Completed

Conditions: Influenza, Human; Birth Defect; Pregnancy

Treatments: Biological: Afluria Influenza Vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT03442582

CSLCT-OBS-17-15

Details and patient eligibility

About

The study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with Afluria during pregnancy.

Enrollment: 490 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Enrollment and data collection will be coordinated through a coordination center (CC). The minimum eligibility criteria required for enrollment are as follows:

• Sufficient information to confirm that the exposure of interest occurred during pregnancy and at which date.
• Sufficient information to determine whether it concerns a prospectively enrolled subject, since retrospective cases are ineligible for enrollment.
• Reporter (e.g. HCP) contact information to allow for follow-up

Exclusion criteria

• N/A

Trial design

490 participants in 1 patient group

Afluria

Description:

Afluria exposure in pregnancy

Treatment:

Biological: Afluria Influenza Vaccine