Drugs / Flublok Quadrivalent
Flublok Quadrivalent
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Supemtek Tetra (previously Supemtek) | — | 2020-11-16 | europa.eu ↗ |
Trials 8 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06118151 | Apr 2022 → Feb 2023 | influenza | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03658629 | Sep 2018 → Apr 2019 | influenza | Novavax | Terminated | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT05144945 | Dec 2021 → Sep 2022 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT03460743 | Mar 2018 → Oct 2019 | influenza | Laboratorios Liomont | Completed | No outcome recorded |
| Phase 3 | NCT02290509 | Oct 2014 → May 2015 | influenza | Protein Sciences Corporation | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT05518500 | Aug 2022 → Dec 2026 expected | premature aging syndrome | The Jackson Laboratory | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03969641 | Sep 2019 → Sep 2021 | — | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT03598439 | Jul 2018 → Mar 2020 | influenza | Marshfield Clinic Research Foundation | Completed | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06361875 Comparator | Apr 2024 → Jun 2025 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 1/2 | NCT05650554 Comparator | Dec 2022 → Apr 2024 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 1/2 | NCT05553301 Comparator | Oct 2022 → Jan 2024 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05514002 Comparator | Sep 2022 → Dec 2023 | influenza | Fatimah Dawood | Terminated | No outcome recorded |
Press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-09-28 | Sanofi | Sanofi to focus its COVID-19 development efforts on the recombinant vaccine candidate sanofi.com ↗ |
| 2021-02-22 | Sanofi | Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate sanofi.com ↗ |
| 2020-12-11 | Sanofi | Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly sanofi.com ↗ |
| 2020-11-18 | Sanofi | European Commission approves Supemtek® (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older sanofi.com ↗ |
| 2020-10-28 | Sanofi | Sanofi and GSK to support COVAX with 200 million doses of adjuvanted, recombinant protein-based COVID-19 vaccine sanofi.com ↗ |
| 2020-09-22 | Sanofi | CHMP recommends approval of Supemtek® (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older sanofi.com ↗ |
| 2020-09-03 | Sanofi | Sanofi and GSK initiate Phase 1/2 clinical trial of COVID-19 adjuvanted recombinant protein-based vaccine candidate sanofi.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Flublok Quadrivalent | “Flublok Quadrivalent® (Quadrivalent Recombinant Influenza Vaccine, Seasonal Formulation)” NCT03460743 ↗6“Sponsor Product Identifiers Flublok® Quadrivalent of Laboratories Liomont, S.A. de C.V.” NCT03460743 ↗ “a single dose of RIV (Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain)” NCT05514002 ↗ “Participants will receive Flublok Quadrivalent in the 2024-2025 flu season.” NCT05518500 ↗ |
| Known as | Quadrivalent Recombinant Influenza Vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05650554 ↗ |
| Known as | Recombinant | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03598439 ↗ |
| Known as | RIV4 | “Quadrivalent Recombinant Influenza Vaccine (RIV4)” NCT05144945 ↗ |
| Modality | Vaccine | “A new quadrivalent recombinant influenza vaccine (RIV4)” PMID 28968871 ↗ Dec 2017 |
| Route | Intramuscular | “Intramuscular injection of vaccine containing 4 x 45µg (180µg total)” NCT02290509 ↗ |