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

NCT05517174 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 332438

Last updated 2025-09-12

No results posted yet for this study

Summary

The purpose of this pragmatic randomized trial is to evaluate the relative vaccine effectiveness of high-dose quadrivalent influenza vaccine (QIV-HD) vs. standard-dose quadrivalent influenza vaccine (QIV-SD) in older adults. Participants will be randomized 1:1 to either QIV-HD or QIV-SD.

Conditions

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.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Statens Serum Institut

    collaborator OTHER

  • Tor Biering-Sørensen

    lead OTHER

Principal Investigators

  • Tor Biering-Sørensen, MD, PhD, MPH · Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-22
Primary Completion
2025-05-31
Completion
2025-08-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05517174 on ClinicalTrials.gov