Drugs / GSK134612
last change Jun 2020 re-read 2 minutes ago

GSK134612

also known as MenACWY-TT · Nimenrix

Vaccine

Developed for
meningococcal infection
Investigated by
GlaxoSmithKline · Pfizer

Trials 21 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 24 trials
Phase 2 NCT01165242 Aug 2010 → Feb 2011 meningococcal infection GlaxoSmithKline Completed No outcome recorded
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
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 No outcome recorded
Phase 3 NCT01767376 Jan 2013 → Jan 2014 meningococcal infection GlaxoSmithKline Completed No outcome recorded
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 No outcome recorded
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
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT00496015 Comparator Jul 2007 → Mar 2008 streptococcal infection GlaxoSmithKline Completed No outcome recorded

Press releases naming this drug 3 releases

DateIssuerRelease
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

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 24 sources stand behind the page.

FieldValueCited text
Known as GSK134612 “Subjects were vaccinated with vaccine GSK134612 Lot A” NCT01165242
23

“GSK Biologicals' meningococcal vaccine GSK 134612” NCT00955682

NCT00955682

NCT00661557

NCT01777308

NCT00471081

NCT01755689

NCT00496015

NCT01962207

NCT00453986

NCT01235975

NCT01340898

NCT00674583

NCT00474266

NCT00718666

NCT01934140

NCT01165242

NCT01767376

NCT01641042

NCT01154088

NCT01939158

NCT00464815

NCT00758264

NCT00508261

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 2020
2

“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