Drugs / Fluad
Fluad
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 13
| 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 11 trial | ||||||
| Phase 1 | NCT03312699 | Sep 2017 → Dec 2023 | hepatitis A virus infection, influenza, typhoid fever | Stanford University | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT05291676 | Nov 2023 → Apr 2027 expected | influenza | Yale University | Recruiting | 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 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT03699839 | Oct 2018 → Aug 2020 | disease related to solid organ transplantation, influenza | Oriol Manuel | Completed | Met primary |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT04583995 | Sep 2020 → Mar 2022 | COVID-19 | Novavax | Completed | Met primary |
| Phase 3 | NCT02255279 | Oct 2014 → May 2015 | influenza | Novartis Vaccines | Completed | Met primary |
| Phase 3 | NCT01032395 | Mar 2010 → Oct 2011 | diabetes mellitus, heart disorder, lung disorder, swine influenza | Chiltern Pesquisa Clinica Ltda | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02871206 | Nov 2016 → Jun 2019 | influenza | McMaster University | 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 |
| Comparator or background therapy14 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 4 | NCT07805837 Comparator | Oct 2025 → Jan 2026 | influenza | Korea University Guro Hospital | 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 | 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 | 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 | NCT02225327 Comparator | Oct → Dec 2013 | 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 | NCT01368796 Comparator | Jul → Dec 2011 | — | University of British Columbia | Completed | No outcome recorded |
| — | 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 |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-05-13 | CSL Behring | Results Published Large U.S. Study Finds Comparable Effectiveness Between Adjuvanted and High-Dose Influenza Vaccines in Adults 65 Years and Older csl.com ↗
Adjuvanted and high-dose influenza vaccines did not differ in effectiveness against laboratory-confirmed influenza in any setting or influenza with emergency department visits or hospitalization. |
| 2025-10-21 | CSL Behring | Results Enhanced Influenza Vaccines Provide Essential Protection for Older Adults: CSL Seqirus Presents New Evidence Supporting Broader Adoption Across Europe csl.com ↗
These new data support the strategic importance of FLUAD and other enhanced vaccines in improving outcomes for older populations. |
| 2022-09-26 | CSL Behring | Results New Real-World Data Presented at OPTIONS XI Show Cell-Based and MF59®-Adjuvanted Influenza Vaccines Can Reduce the Burden of Seasonal Influenza on Hospitals and Health Systems csl.com ↗
CSL Seqirus, a business of CSL Limited (ASX:CSL), today announced new data from four real-world studies showing the impact that cell-based and adjuvanted influenza vaccines can have in reducing the burden of seasonal influenza on hospitals and health systems. |
| 2021-12-07 | CSL Behring | Results New Data Supports the Effectiveness of Adjuvanted Seasonal Influenza Vaccine in Reducing Influenza-Related Hospitalizations and Healthcare Costs in Older Adults csl.com ↗
In this study, findings demonstrated that aTIV was associated with 12% lower risk of hospitalization and a 37% lower risk of respiratory-related hospitalizations compared with TIV and QIV. |
| 2021-09-29 | Pfizer | Results Positive Top-line Results of Pfizer’s Phase 3 Study Exploring Coadministration of Prevnar 20™ With Seasonal Flu Vaccine in Older Adults Released pfizer.com ↗
Responses elicited by PREVNAR 20 for all 20 serotypes and by seasonal influenza vaccine when given together were noninferior (the study’s primary immunogenicity objectives) to those elicited by the vaccines when administered one month apart. |
| 2020-06-08 | CSL Behring | Regulatory First adjuvanted quadrivalent influenza vaccine receives EU approval csl.com ↗
The European Commission has today given regulatory approval for the first adjuvanted quadrivalent influenza vaccine to become available across Europe. |
| 2020-03-31 | CSL Behring | Regulatory Seqirus announces positive CHMP Opinion for its adjuvanted quadrivalent influenza vaccine csl.com ↗ |
| 2019-12-09 | CSL Behring | Results 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 ↗
Researchers reported that in their intent-to-treat analysis, residents offered FLUAD experienced 6 percent fewer hospitalizations from all causes compared with those who received a standard non-adjuvanted TIV (adjusted hazard ratio 0.94, 95% CI: 0.89, 0.99, p=0.02). |
All press releases naming this drug 8 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 30 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 ↗28“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 ↗ “Intervention: MF59-adjuvanted vaccine (FLUAD®) Dose: 0.5 mL intramuscular injection, single dose” NCT07805837 ↗ “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 | aTIV | “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 20181“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 | 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 ↗1“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 | “inactivated influenza virus vaccine” NCT01032395 ↗ |
| Route | Intramuscular | “It is given into the muscle of the upper arm at a dose of 0.5 mL.” NCT01368796 ↗ |