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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)

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ClinicalTrials.gov Identifier: NCT05048589
Recruitment Status : Completed
First Posted : September 17, 2021
Last Update Posted : August 23, 2022
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Tor Biering-Sørensen, Herlev and Gentofte Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Influenza Drug: Standard-Dose Quadrivalent Influenza Vaccine Drug: High-Dose Quadrivalent Influenza Vaccine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12551 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 1, 2021
Actual Primary Completion Date : May 31, 2022
Actual Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

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 Name: 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 Name: QIV-HD




Primary Outcome Measures :
  1. Number of persons contacted by recruitment letter [ Time Frame: Up to 8 months ]
  2. Number of participants included and randomized to QIV-HD or QIV-SD [ Time Frame: Up to 8 months ]
  3. Agreement between randomization assignment and actual received vaccine [ Time Frame: Up to 8 months ]
  4. Balance between groups in terms of number of subjects in each arm and baseline characteristics [ Time Frame: Up to 8 months ]
  5. 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 ]
  6. 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 ]
  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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



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Ages Eligible for Study:   65 Years to 79 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05048589


Locations
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Denmark
Cardiovascular Non-Invasive Imaging Research Laboratory, Department of Cardiology, Herlev and Gentofte Hospital
Hellerup, Denmark, 2900
Danske Lægers Vaccinations Service
Søborg, Denmark, 2860
Sponsors and Collaborators
Tor Biering-Sørensen
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Chair: Tor Biering-Sørensen, MD, PhD, MPH Research Director
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tor Biering-Sørensen, Research Director, MD, PhD, MPH, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier: NCT05048589    
Other Study ID Numbers: DANFLU-1
QHD00027 ( Other Identifier: Sanofi Pasteur )
2021-003170-31 ( EudraCT Number )
First Posted: September 17, 2021    Key Record Dates
Last Update Posted: August 23, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Sharing of individual-level data stemming from Danish administrative registries is illegal according to Danish law.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tor Biering-Sørensen, Herlev and Gentofte Hospital:
Influenza
Vaccination
Pragmatic
Registry
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs