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

Tor Biering-Sørensen

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: High-Dose Influenza Vaccine; Biological: Standard-Dose Influenza Vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06506812

DANFLU/GALFLU pooled analysis

Details and patient eligibility

About

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.

Enrollment: 466,320 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pragmatic trials conducted to estimate the relative vaccine effectiveness of high-dose influenza vaccine compared with standard-dose influenza vaccine using the DANFLU-2 protocol or a protocol developed based on the DANFLU-2 protocol

Exclusion criteria

• Low data quality
• Influenza circulation threshold was not met in any of the study seasons
• Severe under-enrollment in all seasons

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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466,320 participants in 2 patient groups

High-Dose Influenza Vaccine

Experimental group

Description:

Single injection of high-dose influenza vaccine at Day 0

Treatment:

Biological: High-Dose Influenza Vaccine

Standard-Dose Influenza Vaccine

Active Comparator group

Description:

Single injection of standard-dose influenza vaccine at Day 0

Treatment:

Biological: Standard-Dose Influenza Vaccine