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Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2021/22
Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2021/22

NCT05078060

CompletedN/A

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Influenza (Healthy Volunteers)

Interventions: Quadrivalent Influenza Vaccine, High-Dose Quadrivalent Influenza Vaccine

Countries: Finland, Germany

The primary objective of the study is to estimate the reporting rate of suspected Adverse Drug Reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the Northern Hemisphere (NH) influenza season 2021/22. The secondary objectives of the study are: * To estimate the reporting rates of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® according to the pre-defined age groups. * To estimate the reporting rates of serious suspected ADRs after vaccination with VaxigripTetra®, and Efluelda®, respectively, at any time following vaccination, within the Enhanced Passive Safety Surveillance (EPSS) period. * To compare vaccinees' reporting rates of suspected ADRs observed during the NH influenza season 2021/22.

Eligibility overview

Sex: ALL

Age: 6 Months to

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria
Individuals who approach the site for vaccination and agree to receive a vaccination card will be included and vaccinated with the respective vaccine brand according to the country of their location, recommendations for the individual vaccines as well as national recommendations.
Locations (15)
  • Helsinki, Finland
  • Jyväskylä, Finland
  • Kuopio, Finland
  • Tampere, Finland
  • Turku, Finland
  • Blankenhain, Germany
  • Bochum, Germany
  • Donaueschingen, Germany
  • Düsseldorf, Germany
  • Frankfurt am Main, Germany
  • Fulda, Germany
  • Grafenrheinfeld, Germany
  • Haar, Germany
  • Hamburg, Germany
  • Wendelstein, Germany