Drugs / Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT01416571 | Aug → Nov 2011 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00742885 | Sep 2008 → Mar 2009 | influenza | GlaxoSmithKline | Completed | Met primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT00616928 | Jan → Oct 2008 | influenza | GlaxoSmithKline | Completed | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2013-11-25 | GlaxoSmithKline | Regulatory H5N1 vaccine approved by the U.S. FDA as pandemic influenza preparedness measure gsk.com ↗
GSK received notification of the FDA approval late Friday afternoon (22 November). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2013-11-25 | GlaxoSmithKline | H5N1 vaccine approved by the U.S. FDA as pandemic influenza preparedness measure gsk.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01416571 ↗ |
| Known as | GSK1557484A | “This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A, prepared from old concentrated monobulk material” NCT01416571 ↗ |
| Modality | Vaccine | “AS03(A)-adjuvanted H5N1 candidate vaccine” PMID 21606531 ↗ Jun 2011 |
| Route | Intramuscular | “Two intramuscular injections at Days 0 and 21.” NCT00616928 ↗ |