NCT05568979

Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2022/23

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 2022/23.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,001 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

This is an enhanced passive safety surveillance conducted in routine clinical care setting. Spontaneously reported ADRs will be collected by study staff following routine vaccination. 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 2022/23. The secondary objectives of the study are: * To estimate the vaccinee reporting rate of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, according to the pre-defined age groups (not applicable for Efluelda®) * To estimate the vaccinee reporting rate of serious suspected ADRs after vaccination with VaxigripTetra® and Efluelda®, respectively, at any time following vaccination, within the EPSS

Detailed description

Study duration per participant 2 months (including 6 weeks for VC distribution + 2 weeks for vaccinee reporting) following the first vaccination

Conditions

• Influenza (Healthy Volunteers)

Interventions

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

Timeline

• Start date: 2022-10-06
• Primary completion: 2022-11-29
• Completion: 2022-11-29
• First posted: 2022-10-06
• Last updated: 2024-03-13

Locations

15 sites across 2 countries: Finland, Germany