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

Sanofi

Status

Completed

Conditions

Influenza (Healthy Volunteers)

Treatments

Biological: High-Dose Quadrivalent Influenza Vaccine

Biological: Quadrivalent Influenza Vaccine

Study type

Observational

Funder types

Industry

Identifiers

NCT05078060

FLU00170

Details and patient eligibility

About

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.

Full description

Study duration per participant is maximum 2 months.

Enrollment

1,804 patients

Sex

All

Ages

6+ months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.