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NCT06141655 Clinical Trial

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

Influenza Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06141655
Other study ID # GALFLU
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 26, 2023
Est. completion date August 2025

Study information
Verified date November 2023
Source Hospital Clinico Universitario de Santiago
Contact Federico Martinón Torres, PhD, MD
Phone +34 981955373
Email federico.martinon.torres@sergas.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 114011
Est. completion date August 2025
Est. primary completion date May 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 79 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Spain General Public Health Directorate of Galician Health Service Santiago de Compostela A Coruña

Sponsors (1)
Lead Sponsor Collaborator
Federico Martinón Torres

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of a hospitalization due to influenza or pneumonia =14 days after vaccination and up to May 31 the following year
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