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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41807
• EU PAS number:
  EUPAS6521
• Study ID:
  41807
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The purpose of this pregnancy registry study is to detect and describe abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with any of GlaxoSmithKline (GSK) Biologicals’ seasonal Inactivated Influenza Vaccines (sIIVs): Fluarix, FluLaval, Fluarix Quadrivalent and FluLaval Quadrivalent.This study is a transition of existing ongoing pregnancy registries for Fluarix/ FluLaval/Fluarix Quadrivalent/ FluLaval Quadrivalent into one post-authorization safety study (PASS).Pregnancy outcome data will be collected using questionnaires within 2 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD (for all live births) to ascertain the presence of birth defects not diagnosed before, from Q2 2014 to Q2 2019.The intent of the Registry is to prospectively collect data such as vaccination with GSK sIIVs during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy.
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Actual: 13/05/2014

Study start date

Actual: 01/06/2014

Date of final study report

Actual: 01/05/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline (GSK) Biologicals

Study protocol

Initial protocol

201476-Protocol-Redaction

Updated protocol

gsk-201476-protocol-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)