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| Withdrawn | EU (EMA) | Pandemrix | — | 2015-08-13 | europa.eu ↗ |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 6
| 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 21 trial | ||||||
| Phase 2 | NCT00968890 | Sep 2009 → Sep 2010 | influenza | GlaxoSmithKline | 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 applicable1 trial | ||||||
| — | NCT01039623 | Jan 2010 → Dec 2011 | — | Hadassah Medical Organization | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2011-07-21 | GlaxoSmithKline | Regulatory GlaxoSmithKline European regulatory update on Pandemrix™ gsk.com ↗
GlaxoSmithKline (GSK) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended an update to the product label for the H1N1 influenza vaccine, Pandemrix. |
| 2011-04-15 | GlaxoSmithKline | Regulatory GSK European regulatory update on Pandemrix™ gsk.com ↗
GlaxoSmithKline (GSK) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended changes to the product label for Pandemrix. |
| 2011-02-18 | GlaxoSmithKline | Regulatory GSK European regulatory update on Pandemrix™ (1) gsk.com ↗
The CHMP has concluded that the data are still insufficient to establish a causal relationship between Pandemrix and narcolepsy and that no changes to the recommendations for use of Pandemrix are proposed. |
| 2010-09-22 | GlaxoSmithKline | Regulatory GSK EU regulatory update on Pandemrix™ gsk.com ↗
The CHMP has further concluded that any temporary restriction on the use of Pandemrix is not considered warranted. |
| 2009-11-22 | GlaxoSmithKline | Results Pandemic 2009 Influenza Update: Pandemrix™ data in children and adolescents from 3 to 17 years of age gsk.com ↗
The trial, which is ongoing, shows that after the first dose of adjuvanted vaccine, a strong immune response was demonstrated in all age groups. |
| 2009-11-09 | GlaxoSmithKline | Results Pandemic 2009 Influenza Update: Pandemrix™ data on co-administration with annual seasonal influenza vaccine (Fluarix®) gsk.com ↗
The trial showed that co-administration of one dose of both vaccines in separate arms, induced a strong response in adults for both the H1N1 pandemic vaccine as well as the seasonal vaccine. |
| 2009-10-27 | GlaxoSmithKline | Results Pandemic 2009 Influenza Update: Pandemrix™ data in an elderly population gsk.com ↗
GSK also announced new results from a clinical trial assessing the use of Pandemrix in adults aged 18 to 85 years of age. |
| 2009-10-23 | GlaxoSmithKline | Results Pandemic (H1N1) 2009 Influenza Update: Experience of GSK’s H1N1 adjuvanted vaccine, Pandemrix™, and preliminary paediatric results gsk.com ↗
Also announced today are preliminary results from the first paediatric clinical trial assessing use of Pandemrix. |
| 2009-10-15 | GlaxoSmithKline | Results Pandemic (H1N1) 2009 Influenza Update: Results from second clinical trial of GSK’s H1N1 adjuvanted vaccine confirm immune response and tolerability gsk.com ↗
In 100% of the subjects receiving the adjuvanted vaccine the resulting hemagglutination-inhibition titres exceeded the regulatory threshold of 1:40 seroprotection after the first dose. |
| 2009-09-30 | GlaxoSmithKline | Regulatory Pandemic (H1N1) 2009 Influenza Update: GSK’s H1N1 ‘Pandemrix’ vaccine receives European Commission Approval gsk.com ↗
GlaxoSmithKline (GSK) confirmed today that the European Commission has granted marketing authorisation of GSK’s pandemic (H1N1) adjuvanted vaccine Pandemrix™ for protection against pandemic H1N1 2009 influenza. |
| 2009-09-24 | GlaxoSmithKline | Regulatory Pandemic (H1N1) 2009 Influenza Update: GSK’s H1N1 ‘Pandemrix’ vaccine receives positive opinion from European Regulators gsk.com ↗
GlaxoSmithKline (GSK) announced today that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion and recommends approval of GSK’s candidate pandemic (H1N1) adjuvanted vaccine Pandemrix™. |
All press releases naming this drug 13 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 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 | 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 ↗ |