Back to resultsA Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults (DANFLU-2)
Primary Purpose
Influenza
Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
High-Dose Quadrivalent Influenza Vaccine
Standard-Dose Quadrivalent Influenza Vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Influenza focused on measuring Influenza, Vaccination, Pragmatic, Registry, Pneumonia, Respiratory, Cardiovascular
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
Sites / Locations
- Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
- Danske Lægers Vaccinations ServiceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High-Dose Quadrivalent Influenza Vaccine
Standard-Dose Quadrivalent Influenza Vaccine
Arm Description
QIV-HD single injection at Day 0
QIV-SD single injection at Day 0
Outcomes
Primary Outcome Measures
Hospitalization for influenza or pneumonia
Secondary Outcome Measures
Hospitalization for any cardio-respiratory disease
All-cause hospitalization
All-cause mortality
Hospitalization for influenza
Hospitalization for pneumonia
Full Information
NCT ID
NCT05517174
First Posted
August 20, 2022
Last Updated
July 27, 2023
Sponsor
Tor Biering-Sørensen
Collaborators
Sanofi, Statens Serum Institut
1. Study Identification
Unique Protocol Identification Number
NCT05517174
Brief Title
A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults
Acronym
DANFLU-2
Official Title
A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tor Biering-Sørensen
Collaborators
Sanofi, Statens Serum Institut
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
The study is a pragmatic, registry-based, open-label, active-controlled, individually randomized trial. The Danish nationwide administrative health registries will be used for data collection including baseline information, follow-up data, and safety monitoring. The study aims to randomize 286,900 participants over 3 influenza seasons. In each season, participants will be individually randomized 1:1 to receive either QIV-HD or QIV-SD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Vaccination, Pragmatic, Registry, Pneumonia, Respiratory, Cardiovascular
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-Dose Quadrivalent Influenza Vaccine
Arm Type
Experimental
Arm Description
QIV-HD single injection at Day 0
Arm Title
Standard-Dose Quadrivalent Influenza Vaccine
Arm Type
Active Comparator
Arm Description
QIV-SD single injection at Day 0
Intervention Type
Biological
Intervention Name(s)
High-Dose Quadrivalent Influenza Vaccine
Other Intervention Name(s)
QIV-HD
Intervention Description
For this arm, the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used as the active comparator.
Intervention Type
Biological
Intervention Name(s)
Standard-Dose Quadrivalent Influenza Vaccine
Other Intervention Name(s)
QIV-SD
Intervention Description
Any standard-dose quadrivalent influenza vaccine administered in the Danish governmental influenza vaccine program may be used.
Primary Outcome Measure Information:
Title
Hospitalization for influenza or pneumonia
Time Frame
≥14 days after vaccination up to 8 months
Secondary Outcome Measure Information:
Title
Hospitalization for any cardio-respiratory disease
Time Frame
≥14 days after vaccination up to 8 months
Title
All-cause hospitalization
Time Frame
≥14 days after vaccination up to 8 months
Title
All-cause mortality
Time Frame
≥14 days after vaccination up to 8 months
Title
Hospitalization for influenza
Time Frame
≥14 days after vaccination up to 8 months
Title
Hospitalization for pneumonia
Time Frame
≥14 days after vaccination up to 8 months
Other Pre-specified Outcome Measures:
Title
Hospitalization for influenza or pneumonia (alternate definition)
Time Frame
≥14 days after vaccination up to 8 months
Title
Hospitalization for pneumonia (alternate definition)
Time Frame
≥14 days after vaccination up to 8 months
Title
Hospitalization for influenza (alternate definition)
Time Frame
≥14 days after vaccination up to 8 months
Title
Hospitalization for any respiratory disease
Time Frame
≥14 days after vaccination up to 8 months
Title
Hospitalization for any cardiovascular disease
Time Frame
≥14 days after vaccination up to 8 months
Title
Hospitalization for myocardial infarction
Time Frame
≥14 days after vaccination up to 8 months
Title
Hospitalization for heart failure
Time Frame
≥14 days after vaccination up to 8 months
Title
Hospitalization for atrial fibrillation
Time Frame
≥14 days after vaccination up to 8 months
Title
Hospitalization for stroke
Time Frame
≥14 days after vaccination up to 8 months
Title
Major adverse cardiovascular events (MACE) defined as a composite of hospitalization for acute myocardial infarction, hospitalization for stroke, and cardiovascular death
Time Frame
≥14 days after vaccination up to 8 months
Title
MACE defined as a composite of hospitalization for acute myocardial infarction, hospitalization for stroke, hospitalization for heart failure, and cardiovascular death (alternate definition #1)
Time Frame
≥14 days after vaccination up to 8 months
Title
MACE defined as a composite of hospitalization for acute myocardial infarction, hospitalization for stroke, and all-cause death (alternate definition #2)
Time Frame
≥14 days after vaccination up to 8 months
Title
Hospitalization requiring mechanical ventilation
Time Frame
≥14 days after vaccination up to 8 months
Title
Laboratory-confirmed influenza
Time Frame
≥14 days after vaccination up to 8 months
Title
Laboratory-confirmed pneumococcal pneumonia
Time Frame
≥14 days after vaccination up to 8 months
Title
Laboratory-confirmed COVID-19
Time Frame
≥14 days after vaccination up to 8 months
Title
Cardio-respiratory mortality
Time Frame
≥14 days after vaccination up to 8 months
Title
Respiratory mortality
Time Frame
≥14 days after vaccination up to 8 months
Title
Cardiovascular mortality
Time Frame
≥14 days after vaccination up to 8 months
Title
In-hospital mortality
Time Frame
≥14 days after vaccination up to 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niklas Dyrby Johansen, MD
Phone
+4520204794
Email
niklas.dyrby.johansen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Tor Biering-Sørensen, MD, PhD, MPH
Phone
+4528933590
Email
tor.biering-soerensen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tor Biering-Sørensen, MD, PhD, MPH
Organizational Affiliation
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Official's Role
Study Chair
Facility Information:
Facility Name
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
City
Hellerup
State/Province
Hovedstaden
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Danske Lægers Vaccinations Service
City
Søborg
ZIP/Postal Code
2860
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carsten S Larsen, MD, DMSc
First Name & Middle Initial & Last Name & Degree
Carsten S Larsen, MD, DMSc
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
In this trial, baseline and endpoint data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.
Learn more about this trial
A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults
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