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High-Dose Quadrivalent Influenza Vaccine

BIOLOGICAL6 trials

Sponsors

Sanofi Pasteur, a Sanofi Company, Tor Biering-Sørensen, Sanofi

Conditions

InfluenzaInfluenza (Healthy Volunteers)Influenza Immunization (Healthy Volunteers)

Phase 2

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
CompletedNCT05048589
Tor Biering-SørensenInfluenza
Start: 2021-10-01End: 2022-05-31Updated: 2022-08-23

Phase 3

Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Taiwanese Adults 65 Years of Age and Older
CompletedNCT04537234
Sanofi Pasteur, a Sanofi CompanyInfluenza (Healthy Volunteers)
Start: 2020-11-10End: 2021-02-09Updated: 2025-09-24

Phase 4

A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults
CompletedNCT05517174
Tor Biering-SørensenInfluenza
Start: 2022-09-22End: 2025-08-31Updated: 2025-09-12

Unknown Phase

Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2021/22
CompletedNCT05078060
Sanofi Pasteur, a Sanofi CompanyInfluenza (Healthy Volunteers)
Start: 2021-10-12End: 2021-12-02Updated: 2023-03-24
Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2022/23
CompletedNCT05568979
Sanofi Pasteur, a Sanofi CompanyInfluenza (Healthy Volunteers)
Start: 2022-10-06End: 2022-11-29Updated: 2024-03-13
Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2023/24
CompletedNCT06059456
SanofiInfluenza Immunization (Healthy Volunteers)
Start: 2023-10-02End: 2023-12-15Updated: 2025-03-24

Related Papers

High-Dose vs Standard-Dose Influenza Vaccine in Older Adults With Diabetes: A Secondary Analysis of the DANFLU-2 Randomized Clinical Trial.
2026-01-12
High-Dose vs Standard-Dose Influenza Vaccine and Cardiovascular Outcomes in Older Adults: A Prespecified Secondary Analysis of the DANFLU-2 Randomized Clinical Trial.
2025-11-016 citations
High-Dose vs. Standard-Dose Influenza Vaccine in Older Patients With Hypertension: A Post Hoc Analysis of DANFLU-1.
2025-11-011 citations
Effects of high-dose versus standard-dose influenza vaccine among patients with chronic lung disease: A prespecified analysis of the DANFLU-1 trial.
2025-11-01
High-Dose Influenza Vaccine Effectiveness against Hospitalization in Older Adults
New England Journal of Medicine2025-08-3019 citations
High-Dose Versus Standard-Dose Influenza Vaccine in Heart Failure: A Prespecified Analysis of the DANFLU-2 Trial
Circulation Heart Failure2025-08-30
Patient-reported outcomes and home-based self-swabs for influenza-like illness events - lessons learned from the 2023/2024 DANFLU-2 Homeswab PRO substudy.
2025-08-22
A pragmatic individually randomized trial to evaluate the effectiveness of high-dose vs standard-dose influenza vaccine in older adults: Rationale and design of the DANFLU-2 trial
American Heart Journal2025-07-307 citations
Time of day for vaccination, outcomes, and relative effectiveness of high-dose vs. standard-dose quadrivalent influenza vaccine: A post hoc analysis of the DANFLU-1 randomized clinical trial.
2024-09-183 citations
Relative Effectiveness of High-Dose Versus Standard-Dose Quadrivalent Influenza Vaccine in Older Adults With Cardiovascular Disease: A Prespecified Analysis of the DANFLU-1 Randomized Clinical Trial
Circulation Cardiovascular Quality and Outcomes2024-08-318 citations
Influenza Vaccine Immune Response in Patients With High-Risk Cardiovascular Disease
JAMA Cardiology2024-04-0713 citations
Effectiveness of high-dose versus standard-dose quadrivalent influenza vaccine against recurrent hospitalizations and mortality in relation to influenza circulation: A post-hoc analysis of the DANFLU-1 randomized clinical trial.
2024-01-2816 citations
A Pragmatic Randomized Feasibility Trial of Influenza Vaccines
NEJM Evidence2023-01-2358 citations
Immunogenicity and safety of high-dose quadrivalent influenza vaccine in older adults in Taiwan: A phase III, randomized, multi-center study.
2022-10-076 citations
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: rationale and design of the DANFLU-1 Trial
Pilot and Feasibility Studies2022-04-2123 citations