A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults

PHASE4CompletedINTERVENTIONAL
Enrollment

332,438

Participants

Timeline

Start Date

September 22, 2022

Primary Completion Date

May 31, 2025

Study Completion Date

August 31, 2025

Conditions
Influenza
Interventions
BIOLOGICAL

High-Dose Quadrivalent Influenza Vaccine

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

BIOLOGICAL

Standard-Dose Quadrivalent Influenza Vaccine

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

Trial Locations (2)

2860

Danske Lægers Vaccinations Service, Søborg

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

Statens Serum Institut

OTHER

lead

Tor Biering-Sørensen

OTHER

NCT05517174 - A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults | Biotech Hunter | Biotech Hunter