Drugs / Fluarix Quadrivalent
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT01702454 | Oct 2012 → May 2013 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT03686514 | Oct 2018 → Jun 2020 | influenza | Emory University | Terminated | No outcome recorded |
| Phase 4 | NCT03701061 | Oct 2018 → Feb 2019 | avian influenza | Emory University | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT03275389 Comparator | Sep 2017 → Mar 2020 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT05827978 Comparator | Apr 2023 → Jun 2024 | influenza | ModernaTX, Inc. | Completed | Met primary |
| Phase 3 | NCT05566639 Comparator | Sep 2022 → Jan 2024 | influenza | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03739112 Comparator | Sep 2018 → May 2019 | respiratory tract infectious disorder, viral infectious disease | Medicago | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2013-04-03 | GlaxoSmithKline | Regulatory GSK announces first four-strain seasonal influenza vaccine granted marketing authorisation in Germany and the UK gsk.com ↗
Following a decentralised procedure, Germany’s Paul Ehrlich Institut (PEI) was the first national regulatory authority in Europe to grant marketing authorisation for this influenza vaccine, followed by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. |
| 2012-12-17 | GlaxoSmithKline | Regulatory FDA Approves GlaxoSmithKline’s four-strain seasonal influenza vaccine for use in the US gsk.com ↗
the U.S. Food and Drug Administration (FDA) has approved FLUARIX® QUADRIVALENT (Influenza Virus Vaccine) |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2013-04-03 | GlaxoSmithKline | GSK announces first four-strain seasonal influenza vaccine granted marketing authorisation in Germany and the UK gsk.com ↗ |
| 2012-12-17 | GlaxoSmithKline | FDA Approves GlaxoSmithKline’s four-strain seasonal influenza vaccine for use in the US gsk.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fluarix Quadrivalent | “A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study” NCT03701061 ↗6“Fluarix Quadrivalent” NCT05827978 ↗ |
| Known as | GSK2321138A | “Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Quadrivalent Seasonal Influenza Candidate Vaccine GSK2321138A, Administered to Children Who Previously...” NCT01702454 ↗ |
| Modality | Vaccine | “GSK Biologicals' Quadrivalent Seasonal Influenza Candidate Vaccine GSK2321138A” NCT01702454 ↗ |
| Route | Intramuscular | “The vaccine was administered intramuscularly in the deltoid region of arm.” NCT01702454 ↗ |