Efluelda
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT05048589 | Oct 2021 → May 2022 | influenza | Tor Biering-Sørensen | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07485855 | Dec 2025 → Apr 2027 expected | hematopoietic and lymphoid cell neoplasm, influenza | Asan Medical Center | Recruiting | No outcome recorded |
| Phase 44 trials · 2 met primary · 1 missed | ||||||
| Phase 4 | NCT06506812 | May 2025 | influenza | Tor Biering-Sørensen | Completed | Met primary |
| Phase 4 | NCT06141655 | Oct 2023 → May 2025 | influenza | Federico Martinón Torres | Completed | Met primary |
| Phase 4 | NCT05517174 | Sep 2022 → May 2025 | influenza | Tor Biering-Sørensen | Completed | Missed primary |
| Phase 4 | NCT05154383 | Nov 2021 → Jul 2022 | — | Centre Hospitalier Annecy Genevois | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT07805837 Comparator | Oct 2025 → Jan 2026 | influenza | Korea University Guro Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-10-20 | Sanofi | Results Press Release: Sanofi’s high-dose influenza vaccine demonstrates superior protection for older adults against hospitalization vs standard-dose sanofi.com ↗
Compared to standard-dose influenza vaccines, Efluelda/Fluzone High-Dose demonstrated a reduction in laboratory-confirmed influenza hospitalizations by an additional 31.9% (95% CI, 19.7 to 42.2; p<0.001) in adults 65 years and over |
| 2021-10-07 | Sanofi | Results Sanofi: Positive results from the first study of high-dose influenza vaccine with a COVID-19 mRNA booster support co-administration recommendations sanofi.com ↗
This is the first study to provide supportive evidence for vaccinating against influenza at the same time as a COVID-19 mRNA booster in seniors. |
All press releases naming this drug 3 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Efluelda | “This randomized controlled trial aims to compare the immunogenicity of three influenza vaccine formulations - high-dose trivalent inactivated vaccine (HD-IIV3; Efluelda),...” NCT07485855 ↗6“For this arm, the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used.” NCT06506812 ↗ “For this arm, the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used.” NCT05517174 ↗ “Intervention: High-dose influenza vaccine (Efluelda®) Dose: 0.7 mL intramuscular injection, single dose” NCT07805837 ↗ “the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used” NCT05048589 ↗ “EFLUELDA, Suspension for injection, one dose” NCT06141655 ↗ |
| Known as | Fluzone High-Dose Quadrivalent | “For this arm, the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used.” NCT05517174 ↗2“For this arm, the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used.” NCT06506812 ↗ “the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used” NCT05048589 ↗ |
| Known as | HD-IIV3 | “This randomized controlled trial aims to compare the immunogenicity of three influenza vaccine formulations - high-dose trivalent inactivated vaccine (HD-IIV3; Efluelda),...” NCT07485855 ↗ |
| Modality | Vaccine | “the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used” NCT05048589 ↗ |
| Route | Intramuscular | “Single intramuscular injection administered during the influenza season.” NCT07485855 ↗ |