Drugs / GSK134612
GSK134612
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT01165242 | Aug 2010 → Feb 2011 | meningococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT00718666 | Oct 2008 → Nov 2013 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00661557 | May → Dec 2008 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00471081 | Jul 2007 → Oct 2008 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 317 trials · 1 met primary | ||||||
| Phase 3 | NCT01934140 | Apr 2014 → Feb 2018 | meningococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01939158 | Oct 2013 → Dec 2019 | meningococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01962207 | Oct 2013 → Dec 2017 | meningococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01777308 | May 2013 → Jul 2014 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01755689 | Jan 2013 → Apr 2014 | meningococcal infection | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT01767376 | Jan 2013 → Jan 2014 | meningococcal infection | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT01641042 | Sep 2012 → Oct 2014 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01340898 | Jan 2012 → Aug 2014 | meningococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01235975 | Nov 2010 → Jul 2011 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01154088 | Aug → Dec 2010 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00955682 | Aug → Dec 2009 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00758264 | Oct 2008 → Jun 2009 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00674583 | May → Sep 2008 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00508261 | Aug 2007 → May 2008 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00474266 | Jun 2007 → Feb 2008 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00464815 | May 2007 → Apr 2008 | meningococcal infection | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT00453986 | Apr → Nov 2007 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT00496015 Comparator | Jul 2007 → Mar 2008 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2016-12-19 | Pfizer | Regulatory Pfizer Receives Approval in the European Union for Nimenrix™ (Meningococcal Group A, C, W-135, and Y Conjugate Vaccine) in Infants Six Weeks of Age and Older pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today the European Commission (EC) has approved an expanded indication for Nimenrix™ (meningococcal group A, C, W-135, and Y conjugate vaccine) for active immunization against invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W-135, and Y (MenACWY) in infants as early as six weeks of age. |
All press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2016-12-19 | Pfizer | Pfizer Receives Approval in the European Union for Nimenrix™ (Meningococcal Group A, C, W-135, and Y Conjugate Vaccine) in Infants Six Weeks of Age and Older pfizer.com ↗ |
| 2015-10-01 | Pfizer | Pfizer Completes Acquisition Of Nimenrix And Mencevax From GlaxoSmithKline pfizer.com ↗ |
| 2015-06-22 | Pfizer | Pfizer Enters Into Agreement To Acquire Nimenrix And Mencevax From GlaxoSmithKline pfizer.com ↗ |
| 2015-06-22 | GlaxoSmithKline | Regulatory update on divestment of Nimenrix and Mencevax gsk.com ↗ |
| 2012-04-27 | GlaxoSmithKline | GlaxoSmithKline receives European authorisation for Nimenrix™ (Meningococcal group A, C, W-135 and Y conjugate vaccine) gsk.com ↗ |
| 2012-02-17 | GlaxoSmithKline | GlaxoSmithKline receives positive opinion in Europe from the CHMP for Nimenrix® gsk.com ↗ |
| 2011-03-02 | GlaxoSmithKline | Regulatory update: Nimenrix® (MenACWY vaccine) gsk.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GSK 134612 | “Subjects were vaccinated with vaccine GSK134612 Lot A” NCT01165242 ↗23“GSK Biologicals' meningococcal vaccine GSK 134612” NCT00955682 ↗ |
| Known as | MenACWY-TT | “This phase 3B, open-label, extension study (NCT01962207) evaluated long-term persistence of antibodies induced by the quadrivalent meningococcal vaccine conjugated to tetanus...” PMID 32598244 ↗ Jun 20202“We assessed co-administration of quadrivalent meningococcal serogroups A, C, W and Y tetanus toxoid-conjugate vaccine (MenACWY-TT), human papillomavirus 16/18 AS04-adjuvanted...” PMID 29789243 ↗ May 2018 “The Vaccine Response and Long-term Antibody Persistence of GSK Biologicals' MenACWY-TT Vaccine (GSK134612) Administered as One Dose at 6 Years Post-MenC Primary Vaccination” NCT01777308 ↗ |
| Known as | Nimenrix | “Meningococcal vaccine GSK134612 (Nimenrix)” NCT00661557 ↗1“Meningococcal vaccine GSK134612 (Nimenrix)” NCT00474266 ↗ |
| Modality | Vaccine | “meningococcal vaccine GSK134612” NCT00453986 ↗ |
| Route | Intramuscular | “One intramuscular dose” NCT00464815 ↗ |