Drugs / FluMist
FluMist
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | FluMist Quadrivalent | influenza | 2023-10-24 | “Supplemental Biologics License Application (sBLA) for the approval of a self- or caregiver-administered option for FluMist Quadrivalent, a needle-free nasal spray, has been...” astrazeneca.com ↗ |
Trials 34
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05921448 | May 2025 → Jul 2026 overdue | influenza | Copenhagen Respiratory Research | Active not recruiting | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT03453801 | Sep 2014 → Jan 2019 | influenza | Stanford University | Completed | No outcome recorded |
| Phase 1 | NCT01674205 | Sep 2012 → Jun 2013 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00906750 | Oct 2008 → Jul 2011 | cancer | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 1 | NCT00231907 | Sep 2005 → Mar 2007 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT01591473 | Apr 2012 → Sep 2014 | influenza | AIM ImmunoTech Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT01248208 | Sep 2010 → Sep 2011 | food allergy | Walter Reed Army Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00091702 | ? → Jan 2006 | HIV infectious disease, influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT01181323 | Sep 2011 → May 2013 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 2 | NCT00461981 | May → Dec 2007 | — | MedImmune LLC | Completed | Mixed |
| Phase 2 | NCT00344305 | May → Jul 2006 | — | MedImmune LLC | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT00325481 | Jun → Dec 2006 | — | MedImmune LLC | Completed | No outcome recorded |
| Phase 3 | NCT00125944 | Jul 2005 → Jan 2006 | influenza | MedImmune LLC | Completed | No outcome recorded |
| Phase 418 trials | ||||||
| Phase 4 | NCT07240922 | Oct 2025 → Oct 2030 expected | influenza | The University of Hong Kong | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07177417 | Sep 2025 → Sep 2026 overdue | — | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 4 | NCT03884296 | Apr 2019 → Nov 2023 | influenza | Stanford University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03023709 | Sep → Dec 2015 | influenza | Stanford University | Terminated | No outcome recorded |
| Phase 4 | NCT03028987 | Nov 2014 → Nov 2015 | influenza | Stanford University | Terminated | No outcome recorded |
| Phase 4 | NCT03028974 | Sep 2014 → Nov 2017 | influenza | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT03023553 | Dec 2012 → Feb 2013 | influenza | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT03023683 | Oct → Nov 2012 | influenza | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT01933048 | Sep 2012 → Oct 2013 | influenza | Henry M. Jackson Foundation for the Advancement of Military Medicine | Completed | No outcome recorded |
| Phase 4 | NCT02141581 | Aug 2011 → Dec 2014 | influenza | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT03020498 | Sep 2010 → Dec 2011 | influenza | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT01987349 | Sep 2009 → Jan 2010 | influenza | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT02133781 | Jul → Dec 2009 | influenza | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT03020472 | Nov 2008 → Jan 2009 | influenza | Stanford University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00385281 | Oct 2006 → Apr 2007 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT00138385 | Aug 2005 → Jun 2007 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT00192218 | Oct 2004 → Apr 2005 | influenza | MedImmune LLC | Completed | No outcome recorded |
| Phase 4 | NCT00138281 | ? → Nov 2005 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT05290792 | Dec 2021 → Oct 2022 | influenza | Emily McDonald | Completed | No outcome recorded |
| — | NCT01938170 | Sep 2014 → Apr 2015 | influenza | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| — | NCT01044095 | Nov 2009 → Jul 2010 | influenza | Armed Forces Research Institute of Medical Sciences, Thailand | Completed | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 1 | NCT00112112 Comparator | Aug 2005 → Mar 2008 | cancer | MedImmune LLC | Completed | No outcome recorded |
| Phase 2 | NCT00480155 Comparator | May → Dec 2007 | — | MedImmune LLC | Completed | No outcome recorded |
| Phase 3 | NCT00192127 Comparator | Aug 2004 → Feb 2005 | influenza | MedImmune LLC | Completed | No outcome recorded |
| Phase 3 | NCT00192335 Comparator | Jul 2004 → Feb 2005 | — | MedImmune LLC | Completed | No outcome recorded |
| Phase 3 | NCT00192491 Comparator | Dec 2000 → Sep 2003 | influenza | MedImmune LLC | Completed | No outcome recorded |
| Phase 4 | NCT03982069 Comparator | Sep 2019 → Dec 2020 | influenza | Richard Zimmerman MD | Completed | No outcome recorded |
| Phase 4 | NCT00538512 Comparator | Sep 2007 → May 2008 | influenza | University of Michigan | Completed | No outcome recorded |
| Phase 4 | NCT00192140 Comparator | Jun → Oct 2004 | influenza | MedImmune LLC | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-04-08 | AstraZeneca | Results AstraZeneca showcases innovation in infectious disease protection at ESCMID Global 2025 astrazeneca.com ↗
Data include 20 years of real-world effectiveness for Fluenz/FluMist |
| 2024-09-20 | AstraZeneca | Regulatory FluMist approved for self-administration in the US astrazeneca.com ↗
FluMist has been approved in the US as the only self-administered influenza vaccine. |
| 2023-10-24 | AstraZeneca | Regulatory US Food and Drug Administration accepts for review AstraZeneca’s Supplemental Biologics License Application for self-administration of FluMist Quadrivalent astrazeneca.com ↗
AstraZeneca’s Supplemental Biologics License Application (sBLA) for the approval of a self- or caregiver-administered option for FluMist Quadrivalent, a needle-free nasal spray, has been accepted for review by the US Food and Drug Administration (FDA). |
| 2023-10-11 | AstraZeneca | Results AstraZeneca reinforces commitment to protecting the most vulnerable from serious infectious diseases at IDWeek 2023 astrazeneca.com ↗
FluMist Quadrivalent data support the potential for a self-administered influenza vaccine to expand access to an important tool for prevention |
| 2016-06-23 | AstraZeneca | Regulatory AstraZeneca provides update on Flumist Quadrivalent Vaccine in the US for the 2016-17 influenza season astrazeneca.com ↗
The updated guidance states the vaccine should not be used in any setting, based on CDC vaccine effectiveness data from the last three influenza seasons in the US, which indicated FluMist Quadrivalent did not demonstrate statistically significant effectiveness in children 2-17 years of age. |
| 2010-10-22 | AstraZeneca | Regulatory European regulator backs nasal spray vaccine FLUENZ for the prevention of seasonal influenza in children astrazeneca.com ↗
The CHMP issued its opinion for marketing this product in Europe for children 24 months to less than 18 years of age. |
| 2009-01-06 | AstraZeneca | Regulatory MedImmune Submits Marketing Authorisation Application in European Union for Intranasal Vaccine to Prevent Seasonal Influenza astrazeneca.com ↗
MedImmune, the global biologics unit of AstraZeneca, announced today that it has submitted a Marketing Authorisation Application (MAA) for its nasal spray live attenuated influenza vaccine (LAIV), which is now being reviewed by the European Medicines Agency (EMEA). |
All press releases naming this drug 8 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 43 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FluMist | “Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.” NCT03884296 ↗42“A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study.” NCT00344305 ↗ “Standard dose LAIV (Flumist®) 0.1 ml administered to maternal subjects intranasally in each nostril for a total of 0.2 mL.” NCT01181323 ↗ “0.2mL nasal spray live attenuated influenza vaccine (FluMist, AstraZeneca)” NCT07240922 ↗ |
| Known as | 2012-2013 trivalent seasonal live attenuated influenza vaccine | “2012-2013 trivalent seasonal live attenuated influenza vaccine (FluMist®)” NCT01674205 ↗ |
| Known as | FluMist Quadrivalent | “FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray” NCT03028974 ↗ |
| Known as | FluMist Seasonal Trivalent Live Attenuated Intranasal Vaccine | “MedImmune, which also provided FluMist Seasonal Trivalent Live Attenuated Intranasal Vaccine for use in the trial.” PMID 23555741 ↗ Mar 2013 |
| Known as | FluMistTM | “Influenza Virus Vaccine Live, Intranasal FluMistTM, a live trivalent nasally administered vaccine” NCT00385281 ↗ |
| Known as | Influenza Virus Vaccine Live | “FluMist, Influenza Virus Vaccine Live” NCT00461981 ↗ |
| Known as | Influenza Virus Vaccine Live, Intranasal | “Influenza Virus Vaccine Live, Intranasal FluMistTM, a live trivalent nasally administered vaccine” NCT00385281 ↗ |
| Known as | LAIV | “0.2 ml of Live attenuated influenza vaccine (LAIV), Flumist® given intranasally (IN)” NCT01181323 ↗ |
| Known as | LAIV4 | “Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.” NCT03023709 ↗ |
| Modality | Vaccine | “FluMist, a cold-adapted live attenuated influenza vaccine, is both immunogenic and effective in HIV infected children” NCT00091702 ↗ |
| Route | Intranasal | “The standard 0.5 mL dose of vaccine or placebo was administered intranasally.” NCT00112112 ↗ |