Drugs / Optaflu
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Optaflu | — | 2017-06-05 | europa.eu ↗ |
| Approved | EU (EMA) | Optaflu | — | 2007-06-01 | europa.eu ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00645411 | Oct 2007 → Feb 2008 | influenza | Novartis | Completed | Mixed |
| Phase 31 trial | ||||||
| Phase 3 | NCT01640314 | Jul → Aug 2012 | influenza | Novartis Vaccines | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00560066 | Nov 2007 → Jul 2008 | influenza | Novartis Vaccines | Completed | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Optaflu | “A Phase 3 Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell...” NCT01640314 ↗2“The safety and immunogenicity of the cell-culture-derived seasonal trivalent influenza vaccine ([CCIV]; Optaflu) has been reported previously in adults and the elderly.” PMID 22301476 ↗ May 2012 “Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture (Optaflu®) or in Embryonated Hen Eggs (Agrippal®)” NCT00560066 ↗ |
| Known as | CCIV | “The safety and immunogenicity of the cell-culture-derived seasonal trivalent influenza vaccine ([CCIV]; Optaflu) has been reported previously in adults and the elderly.” PMID 22301476 ↗ May 2012 |
| Modality | Vaccine | “cell-culture-derived seasonal trivalent influenza vaccine ([CCIV]; Optaflu)” PMID 22301476 ↗ May 2012 |