Drugs / Focetria
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Focetria | — | 2015-08-13 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Focetria | — | 2007-05-07 | europa.eu ↗ |
| Approved | EU (EMA) | Focetria | — | 2007-05-02 | europa.eu ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT01069601 | Feb 2010 → Apr 2011 | immunodeficiency disease | HepNet Study House, German Liverfoundation | Terminated | No outcome recorded |
| Phase 2 | NCT01006681 | Nov 2009 → Apr 2010 | influenza, rheumatic disorder | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01032408 | Apr 2010 → Sep 2011 | HIV infectious disease, swine influenza | Chiltern Pesquisa Clinica Ltda | Completed | No outcome recorded |
| Phase 3 | NCT01032395 | Mar 2010 → Oct 2011 | diabetes mellitus, heart disorder, lung disorder, swine influenza | Chiltern Pesquisa Clinica Ltda | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01022905 | Nov 2009 → Feb 2010 | HIV infectious disease, cancer, disease related to transplantation, rheumatic disorder | University Hospital, Geneva | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT00914771 Comparator | Sep → Dec 2009 | avian influenza | Novartis Vaccines | Completed | No outcome recorded |
| Phase 4 | NCT01079273 Comparator | Dec 2009 → Nov 2010 | influenza | Opera CRO, a TIGERMED Group Company | Completed | No outcome recorded |
| — | NCT01012557 Comparator | Nov 2009 → Sep 2010 | swine influenza | Copenhagen Studies on Asthma in Childhood | Completed | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Focetria | “This study aims to demonstrate the non-inferiority of two doses of H5N1 influenza antigen in non-elderly and elderly adult subjects in order to submit an extension application...” NCT00914771 ↗8“The purpose of this study is explore the antibody and cell mediated immune responses to one injection of Focetria™ pandemic influenza vaccine in healthy adults aged 18-60 years.” NCT01079273 ↗ “Our primary objective was to compare the immune responses conferred by MF59®-adjuvanted vaccine (Focetria®) in H1N1pnd09-naïve pregnant and non-pregnant women.” PMID 23637733 ↗ Apr 2013 “Adverse events increased with age (P=0.01) and were more frequent with Pandemrix® than Focetria® (P=0.03).” PMID 21419775 ↗ Mar 2011 |
| Modality | Vaccine | “Focetria (Monovalent MF59-Adjuvanted vaccine)” NCT01006681 ↗ |
| Route | Intramuscular | “Intra muscular” NCT01006681 ↗ |