Status: Finalised First registered on: 15/09/2016
Last updated on: 22/02/2019
1. Study identification
EU PAS Register NumberEUPAS15277
Official titlePassive Enhanced Safety Surveillance (ESS) of Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) Fluenz Tetra in Children and Adolescents during the early 2015/2016 Influenza Season in England
Study title acronym
Study typeObservational study
Brief description of the studyThis was a passive enhanced safety surveillance (ESS) project on the live-attenuated nasal influenza vaccine, Fluenz Tetra®. The aim of the surveillance was to rapidly detect changes in the frequency or severity of reactions to the vaccination in children during the 2015/2016 influenza season. The surveillance was conducted to satisfy the European Medicines Agency's (EMA) requirement for enhanced safety surveillance for seasonal influenza vaccines in the EU. Children were provided with a Safety Report Card with an integrated consent form following vaccination for completion by their parents in the event that any suspected side effects were experienced. Any data received was collated and analysed and a report submitted to the EMA.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 belongsDSRU
Department/Research group
Organisation/affiliationDrug Safety Research Unit
Website/Homepagewww.dsru.org
Details of (Primary) lead investigator
Title Professor
Last name Shakir
First name Saad
Is this study being carried out with the collaboration of a research network?
Yes
NIHR Clinical Research Network
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed24/07/2015
Start date of data collection01/10/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report10/03/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Lynn
First name Elizabeth
Address line 1Drug Safety Research Unit
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom
Phone number (incl. country code)442380408600 
Alternative phone number 
Fax number (incl. country code) 
Email address elizabeth.lynn@dsru.org
Public Enquiries
Title Professor 
Last name Shakir 
First name Saad 
Address line 1DSRU 
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom 
Phone number (incl. country code)44-2380-408600 
Alternative phone number 
Fax number (incl. country code)44-2380-408609 
Email address saad.shakir@dsru.org 
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