Fluarix®/ FluLaval®/ Fluarix® Quadrivalent/FluLaval® Quadrivalent Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with Fluarix® or Fluarix® Quadrivalent or FluLaval® or FluLaval® Quadrivalent during pregnancy or within 28 days preceding conception

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Drug dispensing/prescription data

  Drug registry

  Electronic healthcare records (EHR)

  Other
• Data sources (types), other:
  Prospective patient-based data collection, Retrospective post-marketing reports and relevant scientific publications were potential sources of additional information.

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  No