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A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500657-17-00
Acronym
DANFLU-2
Enrollment
339700
Registered
2022-06-28
Start date
2022-09-10
Completion date
2025-08-31
Last updated
2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of influenza infection in older adults

Brief summary

Hospitalization due to influenza or pneumonia [composite endpoint]

Detailed description

1) Hospitalization for any cardio-respiratory disease [composite endpoint], 2) All-cause hospitalization, 3) All-cause mortality, 4) Hospitalization for influenza, 5) Hospitalization for pneumonia

Interventions

DRUGCOVID-19
DRUGRNA-BASED VACCINE
DRUGinjektionsvæske

Sponsors

Gentofte Hospital, Sanofi Pasteur
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Hospitalization due to influenza or pneumonia [composite endpoint]

Secondary

MeasureTime frame
1) Hospitalization for any cardio-respiratory disease [composite endpoint], 2) All-cause hospitalization, 3) All-cause mortality, 4) Hospitalization for influenza, 5) Hospitalization for pneumonia

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 3, 2026