Pooled Analysis of Methodologically Harmonized Pragmatic Randomized Trials of High-Dose vs. Standard-Dose Influenza Vaccine Against Severe Clinical Outcomes

PHASE4CompletedINTERVENTIONAL
Enrollment

466,320

Participants

Timeline

Start Date

May 31, 2025

Primary Completion Date

May 31, 2025

Study Completion Date

August 31, 2025

Conditions
Influenza
Interventions
BIOLOGICAL

High-Dose Influenza Vaccine

For this arm, the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used.

BIOLOGICAL

Standard-Dose Influenza Vaccine

Any standard-dose quadrivalent influenza vaccine administered in the governmental influenza vaccine programs may be used.

Trial Locations (1)

2900

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Hellerup

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

collaborator

Hospital Clinico Universitario de Santiago

OTHER

lead

Tor Biering-Sørensen

OTHER