Flucelvax (TIVc or QIVc) Pregnancy Registry

Seqirus

Status: Completed

Conditions: Influenza, Human; Birth Defect; Pregnancy

Treatments: Biological: Flucelvax Quadrivalent Influenza Vaccine; Biological: Flucelvax Trivalent Influenza Vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT03438487

V130_11OB

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 the TIVc or QIVc vaccine during pregnancy.

Enrollment: 692 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

692 participants in 1 patient group

Flucelvax Trivalent or Quadrivalent Influenza Vaccine

Description:

Flucelvax Trivalent or Quadrivalent exposure in pregnancy

Treatment:

Biological: Flucelvax Trivalent Influenza Vaccine

Biological: Flucelvax Quadrivalent Influenza Vaccine