Drugs / Flucelvax
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Flucelvax | — | 2024-11-15 | europa.eu ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT04025580 | Oct 2019 → Jan 2023 | — | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05479370 | Sep 2022 → Apr 2023 | — | Tan Tock Seng Hospital | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT06518577 | Sep → Dec 2024 | influenza | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT05170399 | Sep 2022 → Aug 2026 overdue | lymphoma | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 1 | NCT07340047 Comparator | Aug 2026 → Mar 2028 | influenza | University of Minnesota | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04896086 Comparator | May 2021 → Jan 2024 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT04101838 Comparator | Apr 2021 → May 2026 overdue | influenza | University of Alabama at Birmingham | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03982069 Comparator | Sep 2019 → Dec 2020 | influenza | Richard Zimmerman MD | Completed | No outcome recorded |
| Phase 4 | NCT03734237 Comparator | Nov 2018 → Jul 2022 overdue | influenza | Henry M. Jackson Foundation for the Advancement of Military Medicine | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03614975 Comparator | Sep → Dec 2018 | influenza | Richard Zimmerman MD | Completed | No outcome recorded |
| Phase 4 | NCT03722589 Comparator | Sep 2018 → Jul 2020 | influenza | Centers for Disease Control and Prevention | Completed | No outcome recorded |
| Phase 4 | NCT03068949 Comparator | Oct 2015 → Jun 2020 | influenza | University of Rochester | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2020-12-14 | CSL Behring | Results Seqirus Presents Real-World Data for Cell-Based Quadrivalent Seasonal Influenza Vaccine (QIVc) at ESWI 2020 csl.com ↗
A Late-breaking poster presentation demonstrating that QIVc prevented significantly more influenza-related medical encounters among individuals aged ≥4 years (n=2,113,216) with at least one health condition, compared to QIVe in the 2018/19 U.S. influenza season. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2020-12-14 | CSL Behring | Seqirus Presents Real-World Data for Cell-Based Quadrivalent Seasonal Influenza Vaccine (QIVc) at ESWI 2020 csl.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Flucelvax | “We compared antibody responses in humans vaccinated with Fluzone
(egg-based, n = 23), Fluzone High-Dose (egg-based, n = 16), Flublok (recombinant
protein-based, n = 23), or...” PMID 31598646 ↗ Sep 202012“Flucelvax, Madin-Darby canine kidney (MDCK)-cell-culture based inactivated influenza vaccine.” NCT03734237 ↗ |
| Known as | Flucelvax quadrivalent | “Flucelvax quadrivalent, the only cell-based flu vaccine FDA licensed for use in the United States.” NCT03734237 ↗1“cell culture-based vaccine (Flucelvax™ Quadrivalent by Seqirus, Inc., 15µg of HA per strain)” NCT03722589 ↗ |
| Modality | Vaccine | “Influenza Vaccine” NCT03068949 ↗ |
| Route | Intramuscular | “given intramuscularly” NCT03068949 ↗ |