Flublok
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04484532 | Oct 2017 → Jun 2022 | acute myeloid leukemia, myelodysplastic syndrome | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT03945825 | Jun 2019 → Sep 2020 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00336453 | Oct 2006 → Jul 2007 | influenza | Protein Sciences Corporation | Completed | No outcome recorded |
| Phase 36 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT07365826 | Jan 2026 → Mar 2027 expected | — | Vaxcyte, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05479370 | Sep 2022 → Apr 2023 | — | Tan Tock Seng Hospital | Completed | Met primary |
| Phase 3 | NCT01959945 | Nov 2013 → Jun 2014 | influenza | Protein Sciences Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00539981 | Sep 2007 → May 2008 | influenza | Sanofi | Completed | Missed primary |
| Phase 3 | NCT00539864 | Sep 2007 → Apr 2008 | influenza | Protein Sciences Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00395174 | Oct 2006 → May 2007 | influenza | Protein Sciences Corporation | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07240922 | Oct 2025 → Oct 2030 expected | influenza | The University of Hong Kong | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06518577 | Sep → Dec 2024 | influenza | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT04576377 | Oct 2020 → Dec 2025 | influenza | The University of Hong Kong | Completed | No outcome recorded |
| Phase 4 | NCT03330132 | Oct 2017 → Dec 2025 | influenza | The University of Hong Kong | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 3 | NCT01825200 Comparator | Mar → May 2013 | influenza | Protein Sciences Corporation | Completed | No outcome recorded |
| Phase 4 | NCT04523324 Comparator | Oct 2019 → Jan 2020 | influenza | Centers for Disease Control and Prevention | 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 | 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 |
| — | NCT02872311 Comparator | Sep 2016 → Apr 2018 | — | Marshfield Clinic Research Foundation | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-11-18 | Sanofi | Regulatory European Commission approves Supemtek® (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older sanofi.com ↗
The European Commission has granted a marketing authorization for Supemtek ® , a quadrivalent (four-strain) recombinant influenza vaccine, for the prevention of influenza in adults aged 18 years and older. |
| 2020-09-22 | Sanofi | Regulatory CHMP recommends approval of Supemtek® (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older sanofi.com ↗
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Supemtek® (recombinant influenza vaccine) for active immunization for the prevention of influenza in adults. |
All press releases naming this drug 3 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Flublok | “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 202020“0.5mL Flublok®, Protein Sciences Corporation containing 180μg antigen, 45μg for each influenza strain included with strains recommended by the WHO for the northern hemisphere...” NCT03330132 ↗ “Recombinant baculovirus-expressed hemagglutinin (rHA [FluBlok]) influenza vaccine is unique in avoiding production in eggs and its rapid production capability.” PMID 19716456 ↗ Aug 2009 “repeated influenza vaccination with Flublok, including these responses' associations with age, birth year, and prior vaccination history” NCT04576377 ↗ “Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlok, To a Licensed Vaccine In Elderly Adults” NCT00395174 ↗ “Licensed and FDA approved FluBlok vaccine to be administered to study participants” NCT02872311 ↗ “2018/2019 seasonal Fluzone or Flublok Quadrivalent Influenza Vaccine (QIV)” NCT03945825 ↗ “0.5mL recombinant hemagglutinin influenza vaccine (Flublok, Sanofi)” NCT07240922 ↗ “FluBlok, recombinant HA influenza vaccine.” NCT03734237 ↗ “Flublok” NCT04484532 ↗ |
| Known as | Flublok Quadrivalent | “Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain” NCT03722589 ↗1“Biological: Flublok™ Quadrivalent by Sanofi, Inc.” NCT04523324 ↗ |
| Known as | Seasonal Influenza Vaccine | “Seasonal Influenza Vaccine (SIV) (Flublok)” NCT07365826 ↗ |
| Known as | SIV | “Seasonal Influenza Vaccine (SIV) (Flublok)” NCT07365826 ↗ |
| Modality | Vaccine | “Recombinant baculovirus-expressed hemagglutinin (rHA [FluBlok]) influenza vaccine” PMID 19716456 ↗ Aug 2009 |
| Route | Intramuscular | “FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly” NCT00336453 ↗ |