Influenza
Conditions
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).
Interventions
DRUGInfluenza 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
Sponsors
Federico Martinón Torres
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 79 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of a hospitalization due to influenza or pneumonia | ≥14 days after vaccination and up to May 31 the following year |
Secondary
| Measure | Time frame |
|---|---|
| Hospitalization for any cardio-respiratory disease [composite endpoint] | ≥14 days after vaccination and up to May 31 the following year |
| All-cause hospitalization | ≥14 days after vaccination and up to May 31 the following year |
| All-cause mortality | ≥14 days after vaccination and up to May 31 the following year |
| Hospitalization for influenza | ≥14 days after vaccination and up to May 31 the following year |
| Hospitalization for pneumonia | ≥14 days after vaccination and up to May 31 the following year |
Countries
Spain
Outcome results
None listed