Drugs / Fluad
Fluad
also known as
adjuvanted influenza vaccine · ATIV · MF59-aTIV · Adjuvanted Quadrivalent Influenza Vaccine · Adjuvanted seasonal trivalent inactivated influenza vaccine · Adjuvanted trivalent inactivated subunit influenza vaccine · adjuvanted trivalent influenza vaccine · Fluad Quadrivalent · +1 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Fluad | — | 2024-11-15 | europa.eu ↗ |
Trials 22 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07386509 | Mar 2020 → Nov 2022 | — | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT03312699 | Sep 2017 → Dec 2023 | hepatitis A virus infection, influenza, typhoid fever | Stanford University | Completed | No outcome recorded |
| Phase 1 | NCT00735020 | Jun → Aug 2008 | influenza | Novartis Vaccines | Completed | No outcome recorded |
| Phase 210 trials | ||||||
| Phase 2 | NCT05291676 | Nov 2023 → Apr 2027 expected | influenza | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT02529904 | Aug 2015 → Apr 2016 | influenza | University of Oxford | Completed | No outcome recorded |
| Phase 2 | NCT01819155 | Apr → Sep 2013 | influenza | PATH | Completed | No outcome recorded |
| Phase 2 | NCT01682369 | Sep 2012 → Feb 2013 | influenza | University of Oxford | Completed | No outcome recorded |
| Phase 2 | NCT01651104 | Jul → Aug 2012 | influenza | Novartis Vaccines | Completed | No outcome recorded |
| Phase 2 | NCT01258023 | Nov 2010 → Feb 2012 | immunodeficiency disease | HepNet Study House, German Liverfoundation | Completed | No outcome recorded |
| Phase 2 | NCT00522067 | Jun → Jul 2007 | influenza | Novartis Vaccines | Completed | No outcome recorded |
| Phase 2 | NCT00386113 | Oct → Nov 2006 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00386698 | Oct → Dec 2006 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00377585 | Sep 2006 → Jan 2007 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03699839 | Oct 2018 → Aug 2020 | disease related to solid organ transplantation, influenza | Oriol Manuel | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT04583995 | Sep 2020 → Mar 2022 | COVID-19 | Novavax | Completed | No outcome recorded |
| Phase 3 | NCT02255279 | Oct 2014 → May 2015 | influenza | Novartis Vaccines | Completed | No outcome recorded |
| Phase 3 | NCT01032395 | Mar 2010 → Oct 2011 | diabetes mellitus, heart disorder, lung disorder, swine influenza | Chiltern Pesquisa Clinica Ltda | Completed | No outcome recorded |
| Phase 3 | NCT00644059 | Nov 2007 → Apr 2010 | influenza | Novartis | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT02871206 | Nov 2016 → Jun 2019 | influenza | McMaster University | Completed | No outcome recorded |
| Phase 4 | NCT02882100 | Apr 2016 → Oct 2018 | influenza | Insight Therapeutics, LLC | Completed | No outcome recorded |
| Phase 4 | NCT01222403 | Oct 2010 → Oct 2014 | influenza | Novartis Vaccines | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04515368 | Jun 2016 → Sep 2020 | — | Imperial College London | Completed | No outcome recorded |
Also used as a comparator or background therapy in 17 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05397223 Comparator | May 2022 → Feb 2026 | COVID-19, cytomegalovirus infection, influenza, respiratory syncytial virus infectious disease | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00559975 Comparator | Oct 2007 → May 2008 | influenza | Novartis | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05606965 Comparator | Nov 2022 → Nov 2025 | influenza | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00519064 Comparator | Nov → Dec 2006 | influenza | Novartis Vaccines | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT04101838 Comparator | Apr 2021 → May 2026 overdue | influenza | University of Alabama at Birmingham | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04077424 Comparator | Oct 2019 → Feb 2020 | — | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT03694808 Comparator | Sep 2018 → Jan 2023 | influenza | David H. Canaday | Completed | No outcome recorded |
| Phase 4 | NCT03603509 Comparator | Aug 2018 → Jan 2019 | influenza | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT03183908 Comparator | Aug 2017 → Feb 2019 | — | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT02523287 Comparator | Oct 2014 → Aug 2016 | — | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT02215863 Comparator | Sep 2014 → Mar 2015 | influenza, pneumococcal infection | Korea University Guro Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02686398 Comparator | Oct 2013 → Nov 2014 | end stage renal failure, influenza | Korea University Guro Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02225327 Comparator | Oct → Dec 2013 | influenza, pneumococcal infection | Korea University Guro Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01368796 Comparator | Jul → Dec 2011 | — | University of British Columbia | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT02872311 Comparator | Sep 2016 → Apr 2018 | — | Marshfield Clinic Research Foundation | Completed | No outcome recorded |
| — | NCT02368327 Comparator | Feb → Jul 2015 | — | University of Surrey | Completed | No outcome recorded |
| — | NCT01771367 Comparator | Jan → Jun 2013 | — | University of Surrey | Completed | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-06-08 | CSL Behring | First adjuvanted quadrivalent influenza vaccine receives EU approval csl.com ↗ |
| 2020-03-31 | CSL Behring | Seqirus announces positive CHMP Opinion for its adjuvanted quadrivalent influenza vaccine csl.com ↗ |
| 2019-12-09 | CSL Behring | New Data Demonstrate that FLUAD® (Influenza Vaccine, Adjuvanted) Significantly Reduces Hospitalization Risk for Adults 65+ Living in U.S. Nursing Homes Compared to Standard Trivalent Influenza Vaccine csl.com ↗ |
| 2017-11-16 | CSL Behring | JCVI advocates adjuvanted influenza vaccine for patients aged 65 years and over for 2018-19 influenza season csl.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 43 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FLUAD | “The experimental intervention consists in an intramuscular injection of a MF59-adjuvanted trivalent inactivated influenza vaccine containing 15 µg of antigen per strain...” NCT03699839 ↗27“This observer-blind, randomized Phase III trial assessed the immunogenicity and safety of the MF59-adjuvanted trivalent influenza vaccine FLUAD® (aTIV) and a non-adjuvanted...” PMID 28925801 ↗ Jan 2018 “A Phase 2, Open Label, Uncontrolled, Multicenter Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine...” NCT01651104 ↗ “Fluad (split virion inactivated seasonal trivalent influenza vaccine adjuvanted with MF59C, Northern Hemisphere 2016-17, Seqirus Vaccines and Diagnostics) 0.5 mL. intramuscular. stat.” NCT04515368 ↗ “adjuvanted trivalent influenza vaccine [Fluad; Seqirus UK, Maidenhead] for those ≥65 years” PMID 34800364 ↗ Nov 2021 “Licensed and FDA approved FluAd vaccine to be administered to study participants” NCT02872311 ↗ “mRNA-1010) with a licensed comparator (FLUAD) in adults aged 18-75 years.” PMID 41535296 ↗ Jan 2026 “Novartis Vaccine MF59-adjuvanted Influenza Subunit Vaccine FLUAD®” NCT01222403 ↗ |
| Known as | adjuvanted influenza vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00377585 ↗ |
| Known as | Adjuvanted Quadrivalent Influenza Vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05606965 ↗ |
| Known as | Adjuvanted seasonal trivalent inactivated influenza vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01819155 ↗ |
| Known as | Adjuvanted trivalent inactivated subunit influenza vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00644059 ↗ |
| Known as | adjuvanted trivalent influenza vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02882100 ↗ |
| Known as | ATIV | “The absolute vaccine efficacy rates against all influenza strains (94 of 110 cases were due to vaccine-matched H3N2 viruses) were 86% (95% confidence interval [CI], 74 to 93)...” PMID 21995388 ↗ Oct 20112“This observer-blind, randomized Phase III trial assessed the immunogenicity and safety of the MF59-adjuvanted trivalent influenza vaccine FLUAD® (aTIV) and a non-adjuvanted...” PMID 28925801 ↗ Jan 2018 “adjuvanted flu vaccine (aTIV, FLUAD) vs high-dose flu vaccine (HD-IIV3, FLUZONE HD)” PMID 40373825 ↗ May 2025 |
| Known as | Fluad Quadrivalent | “Fluad Quadrivalent, MF59 adjuvanted 0.5 ml intramuscular injection, standard as recommended by manufacturer” NCT05291676 ↗ |
| Known as | Fluad Vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03603509 ↗ |
| Known as | MF59-aTIV | “This study is intended to evaluate the immunogenicity and safety of concomitant MF59-adjuvanted trivalent influenza vaccine (MF59-aTIV, Fluad) and 23-valent pneumococcal...” NCT02225327 ↗2“Subjects aged ⩾60years were randomized in a 1:1:1 ratio to receive MF59-adjuvanted trivalent inactivated influenza vaccine (MF59-aTIV)+13-valent pneumococcal conjugate vaccine...” PMID 27919632 ↗ Dec 2016 |
| Modality | Vaccine | “candidate adjuvanted vaccine” NCT00377585 ↗ |
| Route | Intramuscular | “single intramuscular (IM) administration” NCT00559975 ↗ |