NCT06059456

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

Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (High Dose Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2023/24

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,078 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

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

Conditions

• Influenza Immunization (Healthy Volunteers)

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Influenza Vaccine	Intramuscular or subcutaneous administration
BIOLOGICAL	High-Dose Quadrivalent Influenza Vaccine	Intramuscular or subcutaneous administration

Timeline

• Start date: 2023-10-02
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2023-09-28
• Last updated: 2025-03-24

Locations

11 sites across 2 countries: Finland, Germany