A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults
Phase 1
Recruiting
- Conditions
- Prevention of influenza infection in older adultsMedDRA version: 20.0Level: PTClassification code: 10022000Term: Influenza Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2022-500657-17-00
- Lead Sponsor
- Gentofte Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 286900
Inclusion Criteria
1) Age 65 years and above (this inclusion criterion will be modified according to the Danish government’s official recommendations for the 2022/2023 and 2023/2024 influenza seasons – i.e. if the Danish government decides to offer QIV-HD to persons aged 80 and above, the trial will only recruit persons aged 65-79 years. If the Danish government does not offer QIV-HD to anyone, the trial will continue to recruit persons aged 65 and above with no upper limit to participation)
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
- Secondary Outcome Measures
Name Time Method