NCT05078060

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

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
• Phase: —
• Study type: Observational
• Enrollment: 1,804 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

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.

Detailed description

Study duration per participant is maximum 2 months.

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: 2021-10-12
• Primary completion: 2021-12-02
• Completion: 2021-12-02
• First posted: 2021-10-14
• Last updated: 2023-03-24

Locations

15 sites across 2 countries: Finland, Germany