Drugs / Fluarix Tetra
Fluarix Tetra
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT05734040 | May → Aug 2023 | influenza | Osivax | Completed | No outcome recorded |
| Phase 2 | NCT05284799 | May → Jul 2022 | influenza | Osivax | Completed | No outcome recorded |
| Phase 2 | NCT05082688 | Sep 2021 → May 2023 | herpes zoster, influenza | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02369341 | Apr → Jun 2015 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06824779 | Dec 2025 overdue | — | University Hospital of Saint-Etienne | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05648357 | Dec 2023 → Feb 2024 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05315024 | Apr 2022 → Sep 2023 | influenza | The University of Hong Kong | Unknown | No outcome recorded |
| — | NCT02557802 | Oct 2015 → Jan 2016 | influenza | University of Surrey | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 3 | NCT04381689 Comparator | Oct 2024 → May 2025 | — | Il-Yang Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT06602024 Comparator | Sep 2024 → Aug 2025 | influenza | ModernaTX, Inc. | Completed | Met primary |
| Phase 3 | NCT05415462 Comparator | Jun 2022 → Sep 2023 | influenza | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03718468 Comparator | Oct 2018 → Jul 2019 | influenza | Medigen Vaccine Biologics Corp. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2018-03-06 | GlaxoSmithKline | Results New clinical data demonstrate high vaccine efficacy of Fluarix Tetra (Influenza Vaccine) in children 6-35 months of age gsk.com ↗
The study met its two primary endpoints, demonstrating 63.2% (97.5% CI: 51.8–72.3) vaccine efficacy against laboratory-confirmed moderate-to-severe influenza, and 49.8% (97.5% CI: 41.8–56.8) vaccine efficacy against influenza of any severity in children six to 35 months of age. |
| 2018-02-15 | GlaxoSmithKline | Regulatory GSK receives European approval for expanded indication for Fluarix Tetra (Influenza Vaccine) for ages six months and older gsk.com ↗
With this approval, healthcare providers would be able to use the same dose of Fluarix Tetra (15 µg of hemagglutinin per virus strain in 0.5 mL) to cover all eligible people from six months of age and older. |
| 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. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-03-06 | GlaxoSmithKline | New clinical data demonstrate high vaccine efficacy of Fluarix Tetra (Influenza Vaccine) in children 6-35 months of age gsk.com ↗ |
| 2018-02-15 | GlaxoSmithKline | GSK receives European approval for expanded indication for Fluarix Tetra (Influenza Vaccine) for ages six months and older gsk.com ↗ |
| 2013-04-03 | GlaxoSmithKline | GSK announces first four-strain seasonal influenza vaccine granted marketing authorisation in Germany and the UK gsk.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fluarix Tetra | “Flu vaccination by one of FLU vaccines in the french market : FluarixTetra® (GSK), VaxigripTetra® (Sanofi-Pasteur), Influvac Tetra® (VIATRIS MEDICAL)” NCT06824779 ↗12“Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0.” NCT02369341 ↗ |
| Known as | FLU D-QIV (GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra) | “FLU D-QIV (GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra)” NCT02369341 ↗ |
| Modality | Vaccine | “Quadrivalent Split Virion Influenza Vaccine” NCT02369341 ↗ |
| Route | Intramuscular | “intramuscularly into the deltoid of the non-dominant arm.” NCT02369341 ↗ |