NCT06141655

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 134,476 (actual)
• Sponsor: Federico Martinón Torres · Academic / Other
• Sex: All
• Age: 65 Years – 79 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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).

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Influenza vaccine	Participants will be individually randomized 1:1 to receive either QIV-HD or QIV-SD, one dose, the day of the inclusion in the trial

Timeline

• Start date: 2023-10-26
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2023-11-21
• Last updated: 2025-08-08

Locations

1 site across 1 country: Spain