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

NCT06506812 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 466320

Last updated 2025-09-12

No results posted yet for this study

Summary

This prespecified analysis will pool the datasets from two pragmatic randomized trials evaluating the relative vaccine effectiveness of high-dose vs. standard-dose influenza vaccine against severe clinical outcomes: the DANFLU-2 (A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults) trial and the GALFLU (Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Adults Aged 65 to 79 Years in Galicia, Spain) trial. The purpose of the pooled analysis is to ensure adequate statistical power for evaluating relative vaccine effectiveness against severe clinical outcomes and to increase generalizability of the results by combining data from two countries.

Conditions

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.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Hospital Clinico Universitario de Santiago

    collaborator OTHER

  • Tor Biering-Sørensen

    lead OTHER

Principal Investigators

  • Tor Biering-Sørensen, MD, MSc, MPH, PhD · 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
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2025-05-31
Completion
2025-08-31

Countries

  • Denmark

Study Locations

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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 NCT06506812 on ClinicalTrials.gov