Status: Finalised First registered on: 04/10/2016
Last updated on: 13/02/2019
1. Study identification
EU PAS Register NumberEUPAS15696
Official titlePilot study: reactogenicity surveillance in Belgium following immunization with seasonal influenza vaccines
Study title acronym
Study typeObservational study
Brief description of the studyBackground: The EMA calls for a strategy for enhanced safety surveillance of seasonal influenza vaccines. In order to mitigate risks associated with potential new safety concerns within the first month after the start of immunisation, the strategy aims to detect a potential increase in reactogenicity and allergic events in near real-time in the earliest vaccinated cohort. Objective: In this pilot study, we will assess the feasibility of conducting a rapid assessment of reactogenicity of seasonal influenza vaccines in Belgium. The primary objective is to assess whether the required data can be collected in a timely manner. Methods: We aim to recruit subjects aged 18 to 65 years who will have received inactivated seasonal influenza vaccine through routine clinical practice in occupational setting. For seven days, subjects will receive a daily SMS with a link to a web-based questionnaire where reactogenicity events and their severity will be solicited.
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 belongsP95
Department/Research group
Organisation/affiliationP95
Website/Homepagewww.P-95.com
Details of (Primary) lead investigator
Title Dr
Last name De Schryver
First name Antoon
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Belgium
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed14/09/201614/09/2016
Start date of data collection06/10/201606/10/2016
Start date of data analysis07/11/201610/10/2016
Date of interim report, if expected
Date of final study report31/12/201601/12/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherP95100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Verstraeten
First name Thomas
Address line 1Koning Leopold III laan 1
Address line 2 
Address line 3 
CityLeuven 
Postcode3001 
CountryBelgium
Phone number (incl. country code)32-474534868 
Alternative phone number 
Fax number (incl. country code) 
Email address tvtomv@gmail.com
Public Enquiries
Title Dr 
Last name Verstraeten 
First name Thomas 
Address line 1Koning Leopold III laan 1 
Address line 2 
Address line 3 
CityLeuven 
Postcode3001 
CountryBelgium 
Phone number (incl. country code)32-474534868 
Alternative phone number 
Fax number (incl. country code) 
Email address tvtomv@gmail.com 
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