Status: Finalised First registered on: 07/10/2014
Last updated on: 16/09/2016
1. Study identification
EU PAS Register NumberEUPAS7626
Official titleA Postmarketing Noninterventional Cohort Study of the Safety of Live Attenuated Influenza Vaccine (LAIV) in Subjects 2 Through 17 Years of Age
Study title acronymFlu vaccine feedback study
Study typeActive surveillance
Brief description of the studyFollowing the introduction of the interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU, the DSRU is conducting a post authorisation safety (PASS) non-interventional cohort study to determine the incidence of adverse events of interest (AEI) following vaccination with the nasal LAIV, Fluenz Tetra® in the authorised age range (children 2-17 years of age) during the 2014/2015 influenza season. The aim of the study is to rapidly detect a clinically significant change (compared to what was known or expected of the previous year’s influenza vaccine) in the frequency and/or severity of expected reactogenicity (local, systemic, or allergic reactions) after administration of nasal LAIV, Fluenz Tetra® in children 2 to 17 years of age that may indicate a potential for more serious risks as the frequency of exposure to the vaccine increases. Vaccinees will be recruited via the mass vaccination programme through GP practices and through the pilot schools vaccination programme. Patient outcomes, validated by GPs where appropriate, will be captured through questionnaires (received via surface mail or the study website) and coded onto the DSRU database. Patients or their guardians will be asked to complete a questionnaire at enrolment and another 14 days after vaccination. Approximately 200 vaccinees consented per age group: (i) 2 years to <5 years (ii) 5 to <11 years (iii) 11 to 17 years, will be recruited although enrolment will continue to ensure the target of a minimum of 100 vaccinees with completed data per age group is reached.
Was this study requested by a regulator?Yes: EMA
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 CRN
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 signed28/07/201428/07/2014
Start date of data collection03/10/201403/10/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report27/02/201518/03/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMedImmune100
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 1DSRU
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom
Phone number (incl. country code)44-2380408600 
Alternative phone number 
Fax number (incl. country code) 
Email address elizabeth.lynn@dsru.org
Public Enquiries
Title Dr 
Last name Lynn 
First name Elizabeth 
Address line 1DSRU 
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom 
Phone number (incl. country code)44-2380408600 
Alternative phone number 
Fax number (incl. country code) 
Email address elizabeth.lynn@dsru.org 
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