Drugs / Flucelvax
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 5 · a red edge is where a trial was stopped
| 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 | ||||||
| Phase 3 | NCT05479370 | Sep 2022 → Apr 2023 | — | Tan Tock Seng Hospital | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT06518577 | Sep → Dec 2024 | influenza | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT06020118 | Sep 2023 → Mar 2024 | COVID-19, 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 |
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07340047 Comparator | Aug 2026 → Mar 2028 expected | influenza | University of Minnesota | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT04896086 Comparator | May 2021 → Jan 2024 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| 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 | NCT02967393 Comparator | Oct 2016 → Feb 2017 | asthma | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT03068949 Comparator | Oct 2015 → Jun 2020 | influenza | University of Rochester | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 15 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 | ccIIV4 | “approved quadrivalent cell culture-based influenza vaccine (ccIIV4, Seqirus)” NCT06020118 ↗ |
| 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 ↗ |
| Known as | quadrivalent cell culture-based influenza vaccine | “an approved quadrivalent cell culture-based influenza vaccine (ccIIV4, Seqirus)” NCT06020118 ↗ |
| Modality | Vaccine | “cell cultured quadrivalent inactivated influenza vaccine (ccIIV4)(Flucelvax®) being used as a surrogate for LAIV4” NCT02967393 ↗ |
| Route | Intramuscular | “0.5 mL intramuscular injection” NCT02967393 ↗ |