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

CompletedN/A

Sponsor: Sanofi

Conditions: Influenza Immunization (Healthy Volunteers)

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

Countries: Finland, Germany

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 overview

Sex: ALL

Age: 6 Months to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

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 Criteria:

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Locations (11)

Helsinki, Finland
Martinsried, Germany
Martinsried, Germany
Martinsried, Germany
Martinsried, Germany
Martinsried, Germany
Martinsried, Germany
Martinsried, Germany
Martinsried, Germany
Martinsried, Germany
Martinsried, Germany