Drugs / Pandemrix
Pandemrix
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Pandemrix | — | 2015-08-13 | europa.eu ↗ |
| Approved | EU (EMA) | Pandemrix | — | 2008-05-20 | europa.eu ↗ |
Trials 8 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00510874 | Jul 2007 → Jun 2008 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT00968890 | Sep 2009 → Sep 2010 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00980850 | Sep → Dec 2009 | influenza | University of Oxford | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00971425 | Sep → Nov 2009 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT01022905 | Nov 2009 → Feb 2010 | HIV infectious disease, cancer, disease related to transplantation, rheumatic disorder | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 4 | NCT01298102 | Oct 2009 → Mar 2010 | immunodeficiency disease, influenza | Erasme University Hospital | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01039623 | Jan 2010 → Dec 2011 | — | Hadassah Medical Organization | Unknown | No outcome recorded |
| — | NCT01003288 | Oct 2009 → Jan 2010 | — | University of Bergen | Completed | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pandemrix | “All had been primed in 2009/2010 with 1 (HC) or 2 (patients) doses of Pandemrix®” PMID 22848378 ↗ Jul 2012 |
| Known as | Adjuvanted influenza H1N1split virion vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01003288 ↗ |
| Known as | GlaxoSmithKline Novel Influenza A H1N1 Split Virion Vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00980850 ↗ |
| Known as | GSK2340272A | “Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region” NCT00968890 ↗1“Pandemrix (GSK investigational influenza GSK2340272A vaccine)” NCT00971425 ↗ |
| Known as | Influenza A/H1N1 2009-AS03 adjuvanted | “Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)” NCT01298102 ↗ |
| Modality | Vaccine | “candidate influenza vaccine” NCT00510874 ↗ |
| Route | Intramuscular | “Two doses administered intramuscularly (IM)” NCT00510874 ↗ |