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NCT05517174 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

Influenza Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05517174
Other study ID # DANFLU-2
Secondary ID 2022-500657-17-0
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 22, 2022
Est. completion date August 31, 2025

Study information
Verified date July 2023
Source Herlev and Gentofte Hospital
Contact Niklas Dyrby Johansen, MD
Phone +4520204794
Email niklas.dyrby.johansen@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 286900
Est. completion date August 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• 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.
• Standard-Dose Quadrivalent Influenza Vaccine
Any standard-dose quadrivalent influenza vaccine administered in the Danish governmental influenza vaccine program may be used.

Locations
Country Name City State
Denmark Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte Hellerup Hovedstaden
Denmark Danske Lægers Vaccinations Service Søborg

Sponsors (3)
Lead Sponsor Collaborator
Tor Biering-Sørensen Sanofi, Statens Serum Institut

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Other Hospitalization for influenza or pneumonia (alternate definition) =14 days after vaccination up to 8 months
Other Hospitalization for pneumonia (alternate definition) =14 days after vaccination up to 8 months
Other Hospitalization for influenza (alternate definition) =14 days after vaccination up to 8 months
Other Hospitalization for any respiratory disease =14 days after vaccination up to 8 months
Other Hospitalization for any cardiovascular disease =14 days after vaccination up to 8 months
Other Hospitalization for myocardial infarction =14 days after vaccination up to 8 months
Other Hospitalization for heart failure =14 days after vaccination up to 8 months
Other Hospitalization for atrial fibrillation =14 days after vaccination up to 8 months
Other Hospitalization for stroke =14 days after vaccination up to 8 months
Other Major adverse cardiovascular events (MACE) defined as a composite of hospitalization for acute myocardial infarction, hospitalization for stroke, and cardiovascular death =14 days after vaccination up to 8 months
Other MACE defined as a composite of hospitalization for acute myocardial infarction, hospitalization for stroke, hospitalization for heart failure, and cardiovascular death (alternate definition #1) =14 days after vaccination up to 8 months
Other MACE defined as a composite of hospitalization for acute myocardial infarction, hospitalization for stroke, and all-cause death (alternate definition #2) =14 days after vaccination up to 8 months
Other Hospitalization requiring mechanical ventilation =14 days after vaccination up to 8 months
Other Laboratory-confirmed influenza =14 days after vaccination up to 8 months
Other Laboratory-confirmed pneumococcal pneumonia =14 days after vaccination up to 8 months
Other Laboratory-confirmed COVID-19 =14 days after vaccination up to 8 months
Other Cardio-respiratory mortality =14 days after vaccination up to 8 months
Other Respiratory mortality =14 days after vaccination up to 8 months
Other Cardiovascular mortality =14 days after vaccination up to 8 months
Other In-hospital mortality =14 days after vaccination up to 8 months
Primary Hospitalization for influenza or pneumonia =14 days after vaccination up to 8 months
Secondary Hospitalization for any cardio-respiratory disease =14 days after vaccination up to 8 months
Secondary All-cause hospitalization =14 days after vaccination up to 8 months
Secondary All-cause mortality =14 days after vaccination up to 8 months
Secondary Hospitalization for influenza =14 days after vaccination up to 8 months
Secondary Hospitalization for pneumonia =14 days after vaccination up to 8 months
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