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

Influenza (Healthy Volunteers) Clinical Trial

Official title: Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2021/22.

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Study duration per participant is maximum 2 months. ;

Related Conditions & MeSH terms

• Influenza (Healthy Volunteers)
• Influenza, Human

• NCT number: NCT05078060
• Study type: Observational
• Source: Sanofi
• Status: Completed
• Start date: October 12, 2021
• Completion date: December 2, 2021