Drugs / PANFLU.1
PANFLU.1
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT01047202 | Dec 2009 → Mar 2010 | influenza | Sinovac Biotech Co., Ltd | Completed | No outcome recorded |
| Phase 4 | NCT01008137 | Oct → Dec 2009 | influenza | Sinovac Biotech Co., Ltd | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2010-01-21 | Sinovac Biotech Co., Ltd | Results 科兴控股2009年十大新闻 sinovac.com ↗
2009年8月17日北京科兴甲型H1N1流感疫苗临床试验结果揭盲，成为全球首个完成临床试验的甲型H1N1流感疫苗； |
| 2009-09-03 | Sinovac Biotech Co., Ltd | Regulatory 北京科兴“盼尔来福.1”获全球首个甲型H1N1流感疫苗注册批件 sinovac.com ↗
2009年9月3日，国家食品药品监督管理局对外宣布，由北京科兴生物制品有限公司生产的甲型H1N1流感病毒裂解疫苗“盼尔来福.1” (PANFLU.1)的注册申请已获审批通过，并颁发药品注册批件，批准疫苗投入使用。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2010-01-21 | Sinovac Biotech Co., Ltd | 科兴控股2009年十大新闻 sinovac.com ↗ |
| 2009-09-03 | Sinovac Biotech Co., Ltd | 北京科兴“盼尔来福.1”获全球首个甲型H1N1流感疫苗注册批件 sinovac.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PANFLU.1 | “Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre.” NCT01047202 ↗ |
| Known as | H1N1 influenza A Vaccine | “H1N1 influenza A Vaccine (PANFLU.1), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm...” NCT01008137 ↗ |
| Known as | Pandemic influenza A/H1N1 vaccine | “Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre.” NCT01047202 ↗ |
| Modality | Vaccine | “H1N1 influenza A Vaccine (PANFLU.1)” NCT01008137 ↗ |
| Route | Intramuscular | “administered as a single 0.5 mL intramuscular injection” NCT01008137 ↗ |