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, Spai
Phase 1
Recruiting
- Conditions
- Prevention of influenza infection in adults aged 65-79 yearsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2023-506977-36-00
- Lead Sponsor
- Complexo Hospitalario Universitario De Santiago
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 114011
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
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the relative vaccine effectiveness of QIV-HD vs. QIV-SD in reducing the risk of hospitalization for influenza or pneumonia [composite endpoint] in adults aged 65 to 79 years.;Secondary Objective: to evaluate the relative vaccine effectiveness of QIV-HD vs. QIV-SD in reducing the risk of the following endpoints in adults aged 65 to 79 years: 1. Hospitalization for any cardio-respiratory disease [composite endpoint] 2. All-cause hospitalization 3. All-cause mortality 4. Hospitalization for influenza 5. Hospitalization for pneumonia;Primary end point(s): The primary endpoint of the study is the occurrence of a hospitalization due to influenza or pneumonia [composite endpoint].
- Secondary Outcome Measures
Name Time Method Secondary end point(s):The secondary endpoints of the study are as follows: 1. Hospitalization for any cardio-respiratory disease [composite endpoint] 2. All-cause hospitalization 3. All-cause mortality 4. Hospitalization for influenza 5. Hospitalization for pneumonia