Status: Planned First registered on: 20/01/2020
Last updated on: 09/12/2020
1. Study identification
EU PAS Register NumberEUPAS33189
Official titleZanamivir 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
Study title acronym208140
Study typeObservational study
Brief description of the studyTo 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 recognised 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsOXON
Department/Research groupOXON Epidemiology
Organisation/affiliationOXON Epidemiology Ltd.
Website/Homepagewww.oxonepi.com
Details of (Primary) lead investigator
Title Professor
Last name GSK Clinical Disclosure Advisor
First name GSK Clinical Disclosure Advisor
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?1
Countries in which this study is being conducted
International study

Germany
Netherlands
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed29/07/201929/07/2019
Start date of data collection13/01/2021
Start date of data analysis
Date of interim report, if expected
Date of final study report04/10/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesGlaxoSmithKline100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name GSK Clinical Disclosure Advisor
First name GSK Clinical Disclosure Advisor
Address line 1980 Great West Road
Address line 2 
Address line 3 
CityBrentford 
PostcodeTW8 9GS 
CountryUnited Kingdom
Phone number (incl. country code)44-2080-475000 
Alternative phone number 
Fax number (incl. country code) 
Email address Pharma.CDR@gsk.com
Public Enquiries
Title Professor 
Last name GSK Clinical Disclosure Advisor 
First name GSK Clinical Disclosure Advisor 
Address line 1980 Great West Road 
Address line 2 
Address line 3 
CityBrentford 
PostcodeTW8 9GS 
CountryUnited Kingdom 
Phone number (incl. country code)44-2080-475000 
Alternative phone number 
Fax number (incl. country code) 
Email address Pharma.CDR@gsk.com 
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