Clinical trial
A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults
Name
DANFLU-2
Description
The purpose of this pragmatic randomized trial is to evaluate the relative vaccine effectiveness of high-dose quadrivalent influenza vaccine (QIV-HD) vs. standard-dose quadrivalent influenza vaccine (QIV-SD) in older adults. Participants will be randomized 1:1 to either QIV-HD or QIV-SD.
Trial arms
Trial start
2022-09-22
Estimated PCD
2025-05-31
Trial end
2025-08-31
Status
Recruiting
Phase
Early phase I
Treatment
High-Dose Quadrivalent Influenza Vaccine
For this arm, the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used as the active comparator.
Arms:
High-Dose Quadrivalent Influenza Vaccine
Other names:
QIV-HD
Standard-Dose Quadrivalent Influenza Vaccine
Any standard-dose quadrivalent influenza vaccine administered in the Danish governmental influenza vaccine program may be used.
Arms:
Standard-Dose Quadrivalent Influenza Vaccine
Other names:
QIV-SD
Size
286900
Primary endpoint
Hospitalization for influenza or pneumonia
≥14 days after vaccination up to 8 months
Eligibility criteria
Inclusion Criteria:
* 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)
* Informed consent form has been signed and dated
Exclusion Criteria:
* There are no specific exclusion criteria for this study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 286900, 'type': 'ESTIMATED'}}
Updated at
2023-07-28
1 organization
2 products
1 indication
Organization
Tor Biering-SørensenIndication
Influenza