Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2023/24

Last updated: March 20, 2025
Sponsor: Sanofi
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

High-Dose Quadrivalent Influenza Vaccine

Quadrivalent Influenza Vaccine

Clinical Study ID

NCT06059456
FLU00172
U1111-1280-6036
FLU00172
  • Ages > 6
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This EPSS will determine the vaccinee reporting rates (RRs) of suspected ADRs following routine vaccination with VaxigripTetra® and Efluelda® respectively, during the NH influenza season 2023/24. The primary objective of this surveillance is to estimate the vaccinee reporting rate (RR) 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 2023/24. Study duration per participant 2 months (including 6 weeks for VC distribution 2 weeks for vaccinee reporting) following the first vaccination

Eligibility Criteria

Inclusion

Inclusion Criteria:

There are no formal inclusion 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

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 2078
Treatment Group(s): 2
Primary Treatment: High-Dose Quadrivalent Influenza Vaccine
Phase:
Study Start date:
October 02, 2023
Estimated Completion Date:
December 15, 2023

Connect with a study center

  • Investigational Site Number : 2460001

    Helsinki, 00290
    Finland

    Site Not Available

  • Investigational Site Number : 2760001

    Martinsried, 82152
    Germany

    Site Not Available

  • Investigational Site Number : 2760002

    Martinsried, 82152
    Germany

    Site Not Available

  • Investigational Site Number : 2760003

    Martinsried, 82152
    Germany

    Site Not Available

  • Investigational Site Number : 2760004

    Martinsried, 82152
    Germany

    Site Not Available

  • Investigational Site Number : 2760005

    Martinsried, 82152
    Germany

    Site Not Available

  • Investigational Site Number : 2760006

    Martinsried, 82152
    Germany

    Site Not Available

  • Investigational Site Number : 2760007

    Martinsried, 82152
    Germany

    Site Not Available

  • Investigational Site Number : 2760008

    Martinsried, 82152
    Germany

    Site Not Available

  • Investigational Site Number : 2760009

    Martinsried, 82152
    Germany

    Site Not Available

  • Investigational Site Number : 2760010

    Martinsried, 82152
    Germany

    Site Not Available

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