Drugs / Nimenrix
Nimenrix
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Nimenrix | — | 2012-04-20 | europa.eu ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 25 trials · 1 met primary | ||||||
| Phase 2 | NCT07286370 | Apr 2026 → Apr 2028 expected | salmonellosis | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 2 | NCT04645966 | Nov 2020 → Sep 2022 | meningococcal infection | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT02548078 | Nov 2015 → May 2017 | viral infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00715910 | Jul 2008 → Apr 2013 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00427908 | Feb → Dec 2007 | meningococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 39 trials · 2 met primary | ||||||
| Phase 3 | NCT07133178 | Feb → Dec 2026 | chikungunya | Valneva Austria GmbH | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04819113 | Apr 2021 → Sep 2022 | meningococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02955797 | Feb → Oct 2017 | meningococcal meningitis | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT01839175 | Apr 2013 → Jul 2014 | meningococcal infection, viral infectious disease | Sanofi Pasteur, a Sanofi Company | Completed | Met primary |
| Phase 3 | NCT01266993 | Jan 2011 → Mar 2014 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01144663 | Jul 2010 → Jun 2012 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00614614 | Feb 2008 → Jul 2009 | meningococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00514904 | Sep 2007 → Sep 2008 | meningococcal infection | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT00465816 | Apr 2007 → Apr 2008 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 1 | NCT05743881 Comparator | Feb 2023 → Aug 2029 expected | respiratory syncytial virus infectious disease | ModernaTX, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03606512 Comparator | Jan 2019 → Nov 2021 | respiratory syncytial virus infectious disease | Janssen Vaccines & Prevention B.V. | Completed | No outcome recorded |
| Phase 2 | NCT06106581 Comparator | Dec 2023 → Jul 2024 | chikungunya | Valneva Austria GmbH | Completed | Met primary |
| Phase 2/3 | NCT04400838 Comparator | May 2020 → Feb 2025 | COVID-19 | University of Oxford | Completed | Met primary |
| Phase 3 | NCT06284915 Comparator | Mar 2024 → Nov 2025 | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT03890367 Comparator | Sep 2019 → Oct 2020 | — | Sanofi Pasteur, a Sanofi Company | Completed | Met primary |
| Phase 3 | NCT03547271 Comparator | Dec 2018 → May 2023 | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Completed | Mixed |
| Phase 4 | NCT02526394 Comparator | Sep 2013 → Mar 2017 | meningococcal meningitis, pertussis | Public Health England | Completed | No outcome recorded |
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 7 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nimenrix | “Participants will receive Nimenrix®: 2-dose schedule (1+1); dose 1 (priming dose) at 6-7 months of age and dose 2 (booster dose) at 12-13 months of age” NCT06284915 ↗21“Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization” NCT07133178 ↗ “Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA” NCT03547271 ↗ “Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.” NCT02955797 ↗ “received a single dose of Nimenrix® vaccine on Day 0.” NCT03890367 ↗ “Meningitec, NeisVacC, Menitorix, Menveo, Nimenrix” NCT02526394 ↗ “active control meningococcal vaccine (Nimenrix)” PMID 41652122 ↗ Feb 2026 “Nimenrix” NCT04400838 ↗ |
| Known as | 134612 | “GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)” NCT00427908 ↗1“Nimenrix (Meningococcal vaccine 134612)” NCT00465816 ↗ |
| Known as | GSK134612 | “GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)” NCT00614614 ↗1“Nimenrix (GSK134612 vaccine)” NCT01266993 ↗ |
| Known as | MCV4-TT | “The immunogenicity and safety of MenACYW-TT (MenQuadfi®) were compared to another quadrivalent meningococcal conjugate vaccine, MCV4-TT (Nimenrix®), when administered in...” PMID 40665158 ↗ Jul 2025 |
| Known as | MenACWY-TT | “a meningococcal A/C/W/Y tetanus toxoid conjugate vaccine (MenACWY-TT; Nimenrix®) in infants were evaluated.” PMID 39883399 ↗ Jan 2025 |
| Modality | Vaccine | “Nimenrix vaccine” NCT00514904 ↗ |
| Route | Intramuscular | “administered intramuscularly” NCT00514904 ↗ |