HD vs SD Quadrivalent Influenza Vaccine in Adults Aged 65 to 79 Years in Galicia

Federico Martinón Torres

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Drug: Influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT06141655

GALFLU

Details and patient eligibility

About

This pragmatic randomized trial is designed to evaluate the relative vaccine effectiveness of QIV-HD vs. QIV-SD in reducing the risk of hospitalization for influenza or pneumonia in adults 65-79 years of age in Galicia during 2023/2024 and 2024/2025 seasons.

Full description

The study is a pragmatic, registry-based, open-label, active-controlled, individually randomized trial using the infrastructure of the Regional Vaccination Program of Galicia for patient recruitment, inclusion, randomization, and vaccine administration and the Galician health registries for data collection including baseline information, follow-up data and safety monitoring. Participants will have the opportunity of receiving all the information for the trial prior to the vaccination appointment. Informed consent will be obtained during the vaccination appointment by the study team prior to their vaccine administration. The participation in the study is voluntary, and only individuals who accept signing the informed consent will be recruited. Participants may withdraw from the study at any point.

The study aims to randomize at least 114.011 participants over 2 influenza seasons (2023/2024 and 2024/2025) with approximately 57,000 participants per season (pending any further potential sample size adjustments following interim analysis).

Enrollment: 134,476 patients

Sex: All

Ages: 65 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1. Age 65-79 years residing in the community (only individuals who are not eligible to receive QIV-HD as part of the standard of care)
• 2. Informed consent form has been signed and dated

Exclusion criteria

• There are no specific exclusion criteria for this study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134,476 participants in 2 patient groups

QIV-HD vaccine

Experimental group

Description:

EFLUELDA, Suspension for injection, one dose

Treatment:

Drug: Influenza vaccine

QIV-SD vaccine

Active Comparator group

Description:

INFLUVAC TETRA, Suspension for injection, one dose

Treatment:

Drug: Influenza vaccine