Feasibility of Randomizing Danish Citizens Aged 65-79 Years to High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in a Pragmatic Registry-Based Setting (DANFLU-1)

August 20, 2022 updated by: Tor Biering-Sørensen
The purpose of the study is to assess the feasibility of identifying, recruiting and randomizing a large sample of Danish citizens aged 65-79 years to high-dose quadrivalent influenza vaccine or standard-dose quadrivalent influenza vaccine in the 2021/2022 influenza season in a registry-based setting using Danish nationwide registries for all data collection including baseline information and outcome assessment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate the feasibility of recruiting and randomizing Danish citizens aged 65-79 years, we aim to randomize 40,000 citizens 1:1 to high-dose quadrivalent influenza vaccine or standard-dose quadrivalent influenza vaccine in a pragmatic, open-label, registry-based design using the infrastructure of Danske Lægers Vaccinations Service (DLVS), an organization responsible for numerous vaccination clinics in Denmark, for recruitment and randomization and Danish nationwide registries for data collection. Citizens will be recruited by DLVS and randomized and vaccinated at the DLVS clinics. All collection of data related to baseline information, outcomes, and safety monitoring will be performed by a central trial site utilizing information from Danish nationwide health registries.

The findings of this pilot trial will indicate whether the conduction of a full-scale, adequately powered pragmatic RCT is feasible within the Danish registry-based framework.

Study Type

Interventional

Enrollment (Actual)

12551

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Cardiovascular Non-Invasive Imaging Research Laboratory, Department of Cardiology, Herlev and Gentofte Hospital
      • Søborg, Denmark, 2860
        • Danske Lægers Vaccinations Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 79 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 65-79 years
  2. Informed consent form has been signed and dated

Exclusion Criteria:

1. Allergy/hypersensitivity towards the influenza vaccines used in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard-Dose Quadrivalent Influenza Vaccine
QIV-SD single injection at Day 0
Drug: Standard-Dose Quadrivalent Influenza Vaccine
For the control arm, the standard-dose quadrivalent influenza vaccines Influvactetra® and Vaxigriptetra will be used.
Other Names:
  • QIV-SD
EXPERIMENTAL: High-Dose Quadrivalent Influenza Vaccine
QIV-HD single injection at Day 0
Drug: High-Dose Quadrivalent Influenza Vaccine
For the control arm, the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used.
Other Names:
  • QIV-HD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of persons contacted by recruitment letter
Time Frame: Up to 8 months
Up to 8 months
Number of participants included and randomized to QIV-HD or QIV-SD
Time Frame: Up to 8 months
Up to 8 months
Agreement between randomization assignment and actual received vaccine
Time Frame: Up to 8 months
Up to 8 months
Balance between groups in terms of number of subjects in each arm and baseline characteristics
Time Frame: Up to 8 months
Up to 8 months
Comparison of baseline characteristics for the QIV-HD and QIV-SD groups to the overall Danish general population aged 65-79 years
Time Frame: Up to 8 months
Up to 8 months
Comparison of baseline characteristics for the QIV-HD and QIV-SD groups to the population aged 65-79 years in the DLVS database used for recruitment
Time Frame: Up to 8 months
Up to 8 months
Description of event rates and calculation of relative vaccine effectiveness for hospitalization for influenza and/or pneumonia
Time Frame: >= 14 days after vaccination up to 8 months post-vaccination
First hospitalization with a primary (A) diagnosis code for influenza or pneumonia of at least 1 night duration
>= 14 days after vaccination up to 8 months post-vaccination
Description of event rates and calculation of relative vaccine effectiveness for hospitalization for respiratory disease
Time Frame: >= 14 days after vaccination up to 8 months post-vaccination
First hospitalization with a primary (A) diagnosis code for respiratory disease of at least 1 night duration
>= 14 days after vaccination up to 8 months post-vaccination
Description of event rates and calculation of relative vaccine effectiveness for hospitalization for cardio-respiratory disease
Time Frame: >= 14 days after vaccination up to 8 months post-vaccination
First hospitalization with a primary (A) diagnosis code for cardio-respiratory disease of at least 1 night duration
>= 14 days after vaccination up to 8 months post-vaccination
Description of event rates and calculation of relative vaccine effectiveness for hospitalization for cardiovascular disease
Time Frame: >= 14 days after vaccination up to 8 months post-vaccination
First hospitalization with a primary (A) diagnosis code for cardiovascular disease of at least 1 night duration
>= 14 days after vaccination up to 8 months post-vaccination
Description of event rates and calculation of relative vaccine effectiveness for hospitalization from any cause
Time Frame: >= 14 days after vaccination up to 8 months post-vaccination
First hospitalization with any diagnosis code of at least 1 night duration
>= 14 days after vaccination up to 8 months post-vaccination
Description of event rates and calculation of relative vaccine effectiveness for all-cause mortality
Time Frame: >= 14 days after vaccination up to 8 months post-vaccination
Death from any cause
>= 14 days after vaccination up to 8 months post-vaccination
Description of event rates and calculation of relative vaccine effectiveness for hospitalization for COVID-19
Time Frame: >= 14 days after vaccination up to 8 months post-vaccination
First hospitalization with a primary (A) diagnosis code for COVID-19 of at least 1 night duration
>= 14 days after vaccination up to 8 months post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tor Biering-Sørensen

Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

  • Study Chair: Tor Biering-Sørensen, MD, PhD, MPH, Research Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2021

Primary Completion (ACTUAL)

May 31, 2022

Study Completion (ACTUAL)

May 31, 2022

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

September 7, 2021

First Posted (ACTUAL)

September 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 20, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DANFLU-1
  • QHD00027 (OTHER: Sanofi Pasteur)
  • 2021-003170-31 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing of individual-level data stemming from Danish administrative registries is illegal according to Danish law.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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