HD vs SD Quadrivalent Influenza Vaccine in Adults Aged 65 to 79 Years in Galicia
- Registration Number
- NCT06141655
- Lead Sponsor
- Federico Martinón Torres
- Brief 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 114011
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- 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)
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- Informed consent form has been signed and dated
- There are no specific exclusion criteria for this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QIV-SD vaccine Influenza vaccine INFLUVAC TETRA, Suspension for injection, one dose QIV-HD vaccine Influenza vaccine EFLUELDA, Suspension for injection, one dose
- Primary Outcome Measures
Name Time Method Occurrence of a hospitalization due to influenza or pneumonia ≥14 days after vaccination and up to May 31 the following year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
General Public Health Directorate of Galician Health Service
🇪🇸Santiago de Compostela, A Coruña, Spain