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

Sanofi

Status

Completed

Conditions

Influenza Immunization (Healthy Volunteers)

Treatments

Biological: Quadrivalent Influenza Vaccine

Biological: High-Dose Quadrivalent Influenza Vaccine

Study type

Observational

Funder types

Industry

Identifiers

NCT06059456

U1111-1280-6036 (Registry Identifier)

FLU00172

Details and patient eligibility

About

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

Enrollment

2,078 patients

Sex

All

Ages

6+ months old

Volunteers

Accepts Healthy Volunteers

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