Zanamivir 10mg/ml solution for infusion pregnancy registry: an observational study of the safety of zanamivir 10mg/ml solution for infusion exposure in pregnant women with complicated influenza and their offspring (208140)

Study identification

• EU PAS number:
  EUPAS33189
• Study ID:
  49381
• Official title and acronym:
  Zanamivir 10mg/ml solution for infusion pregnancy registry: an observational study of the safety of zanamivir 10mg/ml solution for infusion exposure in pregnant women with complicated influenza and their offspring (208140)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The study was cancelled before active. To evaluate pregnancy outcomes among women with complicated influenza exposed to zanamivir 10mg/mL solution for infusion at any time during pregnancy including: 1) maternal death, 2) pregnancy outcomes including spontaneous losses in clinically recognized pregnancies, induced abortions, stillbirths and live births and 3) birth outcomes including low birth weight, small for gestational age, prematurity, congenital malformations and neonatal death.
• Study status:
  Finalised

Research institutions and networks

Institutions

OXON Epidemiology

Spain

United Kingdom

Study timelines

Date when funding contract was signed

Planned:29/07/2019

Actual:29/07/2019

Study start date

Planned:20/11/2020

Actual:20/11/2020

Date of final study report

Planned:19/06/2024

Actual:19/06/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)