Drugs / Arepanrix
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Arepanrix | — | 2010-12-13 | europa.eu ↗ |
| Approved · conditional | EU (EMA) | Arepanrix | — | 2010-03-23 | europa.eu ↗ |
Trials 3 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT01114620 | May → Nov 2010 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01001026 | Nov 2009 → Feb 2010 | swine influenza | David Scheifele | Completed | No outcome recorded |
| Phase 4 | NCT01000584 | Nov 2009 → Feb 2010 | swine influenza | David Scheifele | Completed | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT07240558 Comparator | Nov 2025 → Jun 2026 overdue | avian influenza | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT07275060 Comparator | Oct 2025 → Feb 2027 expected | avian influenza | Canadian Immunization Research Network | Active not recruiting | No outcome recorded |
| Phase 4 | NCT01002040 Comparator | Feb → Jul 2010 | HIV infectious disease, swine influenza | University of British Columbia | Completed | No outcome recorded |
| Phase 4 | NCT01000831 Comparator | Nov 2009 → Feb 2010 | influenza | University of British Columbia | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Arepanrix | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01114620 ↗ |
| Known as | GSK2340274A | “GSK Biologicals' Influenza Vaccine Arepanrix™ (GSK2340274A)” NCT01114620 ↗ |
| Modality | Vaccine | “ASO3-adjuvanted H1N1(2009) vaccine” PMID 21178654 ↗ May 2011 |
| Route | Intramuscular | “Adults: One dose Arepanrix vaccine given IM (0.5 mL)” NCT01001026 ↗ |