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Updated: Mar 11, 2026
Assessing Respiratory Immune Responses to Haemophilus Influenzae
Published on: June 29, 2021
Rapid assessment of the reactogenicity of a 2016-2017 seasonal influenza vaccine: results from a feasibility study
Anke L Stuurman1, Thomas Verstraeten1, Antoon De Schryver2
1a P95 Epidemiology and Pharmacovigilance Consulting and Services , Leuven , Belgium.
Background:
The European Medicines Agency (EMA) calls for a strategy for enhanced safety surveillance of seasonal influenza vaccines.
Objective:
We assessed the feasibility of collecting reactogenicity data within one month of the start of the vaccination campaign in Belgium.
Methods:
One hundred subjects aged 18 to 65 years who had received inactivated seasonal influenza vaccine in occupational setting were enrolled. For 7 days after vaccination, subjects received a daily SMS with a link to a web-based questionnaire where reactogenicity events and their severity were solicited.
Results:
Data collection was completed by October 13th, 2016, before the peak of the vaccination campaign in Belgium. 68% of participants reported a local reaction and 65% a general reaction; 51% reported both a local and a general reaction.
Conclusion:
Here we show that it has been possible to collect reactogenicity data in adults for enhanced safety surveillance in Belgium in a timely manner. The observed reactogenicity is higher compared to previous observations for this vaccine measured in clinical trials.
