Drugs / Influsplit Tetra™
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT02218697 | Oct 2014 → Jan 2015 | influenza | GlaxoSmithKline | Completed | Met primary |
| Comparator or background therapy3 trials | ||||||
| Phase 3 | NCT06602024 Comparator | Sep 2024 → Aug 2025 | influenza | ModernaTX, Inc. | Completed | Met primary |
| Phase 3 | NCT02207413 Comparator | Aug 2014 → Apr 2015 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT03654937 Comparator | Sep → Dec 2016 | — | Saarland University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| 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. |
All press releases naming this drug 1 release
| 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 ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Influsplit Tetra | “Influenza vaccination "Influsplit Tetra" 2016/2017” NCT03654937 ↗ |
| Modality | Vaccine | “split-virion inactivated quadrivalent influenza vaccine (IIV4)” PMID 29669531 ↗ Apr 2018 |
| Route | Intramuscular | “Influsplit Tetra™ vaccine using a new manufacturing process administered intramuscularly (IM) in the deltoid region of non-dominant arm (Dose 1) in Adults Group” NCT02207413 ↗ |