Drugs / Menveo
Menveo
also known as
MenACWY-CRM · GSK's combined meningococcal groups A, C, Y and W-135 conjugate vaccine, Menveo · Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine · Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine · Meningococcal ACWY Conjugate Vaccine
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Menveo | — | 2010-03-15 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Menveo | — | 2009-12-17 | europa.eu ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06128733 | Oct 2023 → Aug 2025 | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02986854 | Dec 2016 → Jul 2017 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00856297 | Feb 2009 → Nov 2012 | meningococcal meningitis | Novartis Vaccines | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT06436274 | Oct 2024 → Dec 2026 expected | HIV infectious disease, human papilloma virus infection | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04875819 | Apr 2021 → Dec 2026 expected | HIV infectious disease, meningococcal infection, pneumococcal infection | Thomas Benfield | Recruiting | No outcome recorded |
| Phase 4 | NCT03682939 | Feb 2019 → Jun 2020 | HIV infectious disease, meningococcal meningitis | St George's, University of London | Unknown | No outcome recorded |
| Phase 4 | NCT02072525 | Apr 2014 → Jun 2015 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Comparator or background therapy15 trials | ||||||
| Phase 1 | NCT05739292 Comparator | Feb → May 2023 | meningococcal infection | EuBiologics Co.,Ltd | Completed | No outcome recorded |
| Phase 1/2 | NCT05073003 Comparator | Oct 2021 → Jun 2025 | diarrheal disease | GlaxoSmithKline | Completed | Missed primary |
| Phase 1/2 | NCT04886154 Comparator | Jun 2021 → Feb 2024 | meningococcal infection | GlaxoSmithKline | Completed | Mixed |
| Phase 2 | NCT07320716 Comparator | Jan 2026 → Oct 2028 expected | diarrheal disease | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07183371 Comparator | Dec 2025 → Dec 2026 expected | Plasmodium falciparum malaria | University of Oxford | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03652610 Comparator | Sep 2018 → Jan 2019 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02676895 Comparator | Aug 2016 → Mar 2017 | shigellosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02199691 Comparator | Jul 2014 → Oct 2015 | meningococcal meningitis | Sanofi Pasteur, a Sanofi Company | Completed | Met primary |
| Phase 2/3 | NCT07204457 Comparator | Oct 2025 → Sep 2026 overdue | meningococcal infection | EyeGene Inc. | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04400838 Comparator | May 2020 → Feb 2025 | COVID-19 | University of Oxford | Completed | Met primary |
| Phase 2/3 | NCT01192997 Comparator | Jun 2012 → Oct 2013 | meningococcal meningitis | Public Health England | Completed | No outcome recorded |
| Phase 3 | NCT03673462 Comparator | Sep 2018 → Mar 2023 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT00901940 Comparator | Jun 2009 → Oct 2010 | bacterial infectious disease with sepsis, meningitis | University of Oxford | Completed | No outcome recorded |
| Phase 4 | NCT03675256 Comparator | Dec 2018 → Feb 2024 | human papilloma virus infection | Massachusetts General Hospital | Unknown | Met primary |
| Phase 4 | NCT02526394 Comparator | Sep 2013 → Mar 2017 | meningococcal meningitis, pertussis | Public Health England | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-11-27 | GlaxoSmithKline | Regulatory GSK’s fully liquid Menveo meningococcal vaccine approved by European Commission gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (Meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y. |
| 2024-09-24 | GlaxoSmithKline | Regulatory GSK’s Menveo meningococcal vaccine in new single-vial, fully liquid presentation receives positive European CHMP opinion gsk.com ↗ |
| 2022-10-17 | GlaxoSmithKline | Regulatory US FDA approves Menveo in a new single-vial presentation to help prevent disease caused by meningococcal bacteria serogroups A, C, Y, and W gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a new presentation of Menveo [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diptheria CRM197 Conjugate Vaccine] for individuals aged 10 to 55 years to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-11-27 | GlaxoSmithKline | GSK’s fully liquid Menveo meningococcal vaccine approved by European Commission gsk.com ↗ |
| 2024-09-24 | GlaxoSmithKline | GSK’s Menveo meningococcal vaccine in new single-vial, fully liquid presentation receives positive European CHMP opinion gsk.com ↗ |
| 2022-10-17 | GlaxoSmithKline | US FDA approves Menveo in a new single-vial presentation to help prevent disease caused by meningococcal bacteria serogroups A, C, Y, and W gsk.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Menveo | “One dose (0.5 ml) of conjugate vaccine against meningococcal serogroups ACWY (Menveo®) and one dose of a recombinant protein-based vaccine against meningococcal serogroup B...” NCT04875819 ↗21“Persistence of immune responses after a single dose of Novartis meningococcal serogroup A, C, W-135 and Y CRM-197 conjugate vaccine (Menveo®) or Menactra® among healthy adolescents.” PMID 21339701 ↗ Nov 2010 “The MenACWY conjugate vaccine was licensed in the UK in March 2010, and is known as the MenACWY conjugate vaccine (Menveo).” NCT00901940 ↗ “Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.” NCT02199691 ↗ “GSK's combined meningococcal groups A, C, Y and W-135 conjugate vaccine, Menveo” NCT04886154 ↗ “Meningitec, NeisVacC, Menitorix, Menveo, Nimenrix” NCT02526394 ↗ “Menveo®” NCT06128733 ↗ “Menveo” NCT04400838 ↗ |
| Known as | GSK's combined meningococcal groups A, C, Y and W-135 conjugate vaccine, Menveo | “GSK's combined meningococcal groups A, C, Y and W-135 conjugate vaccine, Menveo” NCT04886154 ↗ |
| Known as | MenACWY-CRM | “Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55...” NCT02986854 ↗1“The persistence of human bactericidal activity (hSBA) responses in adolescents was assessed 22 months after vaccination with one dose of Menveo® (MenACWY-CRM; Novartis) or...” PMID 21339701 ↗ Nov 2010 |
| Known as | Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine | “Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)” NCT02986854 ↗ |
| Known as | Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine | “Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)” NCT03673462 ↗ |
| Known as | Meningococcal ACWY Conjugate Vaccine | “A Phase 3b, Controlled, Open-Label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's Meningococcal ACWY Conjugate Vaccine...” NCT02986854 ↗ |
| Modality | Vaccine | “MenACWY conjugate vaccine” NCT00901940 ↗ |
| Route | Intramuscular | “given intramuscularly” NCT00901940 ↗ |