Drugs / Menveo

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Menveo 2010-03-15 europa.eu
Refused (EMA) EU (EMA) Menveo 2009-12-17 europa.eu

Trials 61 · started per year

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20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/24 trials
Phase 1/2 NCT06128733 Oct 2023 → Aug 2025 meningococcal infection Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 1/2 NCT04324606 Apr 2020 → Feb 2025 Coronaviridae infectious disease University of Oxford Completed No outcome recorded
Phase 1/2 NCT04056117 Sep 2019 → Sep 2022 shigellosis LimmaTech Biologics AG Completed No outcome recorded
Phase 1/2 NCT01782066 Jan 2013 → Feb 2014 meningococcal infection Leiden University Medical Center Completed No outcome recorded
Phase 215 trials
Phase 2 NCT07286370 Apr 2026 → Apr 2028 expected salmonellosis GlaxoSmithKline Recruiting No outcome recorded
Phase 2 NCT06523231 Apr → Aug 2025 shigellosis LimmaTech Biologics AG Completed No outcome recorded
Phase 2 NCT05082285 Nov 2021 → Mar 2025 meningococcal infection GlaxoSmithKline Completed 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 NCT02324751 Sep 2015 → Dec 2017 typhoid fever University of Oxford Completed No outcome recorded
Phase 2 NCT02097849 Feb 2015 → May 2016 relapsing-remitting multiple sclerosis Biogen Completed No outcome recorded
Phase 2 NCT01018732 Jan → Jul 2010 meningococcal meningitis Novartis Vaccines Completed No outcome recorded
Phase 2 NCT00715910 Jul 2008 → Apr 2013 meningococcal infection GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT00488683 Jul 2007 → May 2009 meningococcal infection Novartis Vaccines Completed No outcome recorded
Phase 331 trials
Phase 3 NCT07133178 Feb → Dec 2026 chikungunya Valneva Austria GmbH Withdrawn No outcome recorded
Phase 3 NCT04819113 Apr 2021 → Sep 2022 meningococcal infection Pfizer Completed No outcome recorded
Phase 3 NCT04440163 Jun 2020 → Jul 2022 meningococcal infection Pfizer Completed No outcome recorded
Phase 3 NCT03189745 Aug 2017 → Apr 2018 meningococcal infection Pfizer Completed No outcome recorded
Phase 3 NCT03135834 Apr 2017 → Oct 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 NCT02986854 Dec 2016 → Jul 2017 meningococcal infection GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT02106390 Jun 2014 → Oct 2016 meningococcal infection GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT01839175 Apr 2013 → Jul 2014 meningococcal infection, viral infectious disease Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 3 NCT01725217 Nov 2012 → Mar 2013 meningococcal infection Novartis Vaccines Completed No outcome recorded
Phase 49 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 NCT03694405 Sep 2018 → Aug 2021 meningococcal infection Canadian Immunization Research Network Completed No outcome recorded
Phase 4 NCT02446691 Jul 2015 → Dec 2017 meningococcal infection GlaxoSmithKline Completed No outcome recorded
Phase 4 NCT02072525 Apr 2014 → Jun 2015 meningococcal infection GlaxoSmithKline Completed No outcome recorded
Phase 4 NCT01823536 May → Oct 2013 meningococcal infection Novartis Vaccines Completed No outcome recorded
Phase 4 NCT01766206 Mar 2013 → Jan 2018 meningococcal infection GlaxoSmithKline Completed No outcome recorded
Phase 4 NCT01424644 Sep 2011 → Dec 2012 meningococcal meningitis Novartis Completed No outcome recorded
Phase not applicable2 trials
NCT06116669 Nov 2023 → Dec 2024 iron deficiency anemia Swiss Federal Institute of Technology Unknown No outcome recorded
NCT05919472 Jul 2023 → Jul 2024 iron deficiency anemia Nicole Stoffel Completed No outcome recorded
Also used as a comparator or background therapy in 40 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT05739292 Comparator Feb → May 2023 meningococcal infection EuBiologics Co.,Ltd Completed No outcome recorded
Phase 1 NCT05743881 Comparator Feb 2023 → Aug 2029 expected respiratory syncytial virus infectious disease ModernaTX, Inc. Active not recruiting No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT05073003 Comparator Oct 2021 → Jun 2025 diarrheal disease GlaxoSmithKline Completed No outcome recorded
Phase 1/2 NCT04886154 Comparator Jun 2021 → Feb 2024 meningococcal infection GlaxoSmithKline Completed 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 213 trials
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 NCT06213506 Comparator Jan 2024 → Sep 2026 expected salmonellosis GlaxoSmithKline Active not recruiting No outcome recorded
Phase 2 NCT06106581 Comparator Dec 2023 → Jul 2024 chikungunya Valneva Austria GmbH Completed No outcome recorded
Phase 2 NCT03929757 Background Aug 2019 → Aug 2022 Ebola hemorrhagic fever Janssen Vaccines & Prevention B.V. Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT07204457 Comparator Oct 2025 → Sep 2026 expected meningococcal infection EyeGene Inc. Recruiting No outcome recorded
Phase 2/3 NCT04400838 Comparator May 2020 → Feb 2025 COVID-19 University of Oxford Completed No outcome recorded
Phase 2/3 NCT01192997 Comparator Jun 2012 → Oct 2013 meningococcal meningitis Public Health England Completed No outcome recorded
Phase 316 trials
Phase 3 NCT06284915 Comparator Mar 2024 → Nov 2025 meningococcal infection Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 3 NCT05093829 Comparator Mar 2022 → Mar 2023 meningococcal meningitis Emory University Completed No outcome recorded
Phase 3 NCT04707391 Comparator Jan 2021 → May 2023 meningococcal meningitis GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT04536051 Comparator Jun 2020 → Sep 2021 COVID-19 University of Oxford Unknown No outcome recorded
Phase 3 NCT03890367 Comparator Sep 2019 → Oct 2020 Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 43 trials
Phase 4 NCT03675256 Comparator Dec 2018 → Feb 2024 human papilloma virus infection Massachusetts General Hospital Unknown No outcome recorded
Phase 4 NCT02526394 Comparator Sep 2013 → Mar 2017 meningococcal meningitis, pertussis Public Health England Completed No outcome recorded
Phase 4 NCT01593514 Comparator Dec 2012 → Apr 2013 bacterial infectious disease with sepsis, meningitis, meningococcal infection University of Oxford Completed No outcome recorded

Press releases naming this drug 5 releases

DateIssuerRelease
2020-11-23 Sanofi European Commission approves MenQuadfi®, the latest innovation in meningococcal (MenACWY) vaccination for individuals 12 months of age and older sanofi.com
2020-04-24 Sanofi FDA approves MenQuadfiTM, the latest innovation in meningococcal (MenACWY) vaccination sanofi.com
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 25 cited values

Every value below carries the sentence it was read from. 106 sources stand behind the page.

FieldValueCited text
Known as Menveo “This was the first study of laboratory workers who received both a conjugate vaccine against meningococcal serogroups A, C, W-135, and Y (Men ACWY-CRM, Menveo) and an...” PMID 21177912 Dec 2010
27

“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

“MenACWY-CRM (Menveo®, Novartis Vaccines, Siena, Italy) is a quadrivalent meningococcal conjugate vaccine developed to help prevent invasive meningococcal disease caused by...” PMID 25075804 Jul 2014

“The MenACWY-CRM conjugate vaccine (Menveo, Novartis) is obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be reconstituted with the...” NCT01593514

“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

“meningococcal serogroup A, C, W-135, and Y (Menveo®, GlaxoSmithKline Biologicals, S.A.)” NCT03165617

“GSK's combined meningococcal groups A, C, Y and W-135 conjugate vaccine, MenveoNCT04886154

“Meningitec, NeisVacC, Menitorix, Menveo, Nimenrix” NCT02526394

“MenACWY (Menveo) vaccine” NCT03587207

“MenACWY-CRM (Menveo)” NCT01766206

Menveo®” NCT06128733

MenveoNCT04400838

NCT02986854

NCT03675256

NCT07183371

NCT03673462

NCT03682939

NCT05073003

NCT07320716

NCT02676895

NCT06436274

NCT01192997

NCT03652610

NCT02072525

NCT05739292

NCT07204457

Known as 134612 “GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)” NCT00427908
1

“Nimenrix (Meningococcal vaccine 134612)” NCT00465816

Known as ACWY Vax “The MenACWY Plain Polysaccharide Vaccine, which is already licensed and is used as a travel vaccine, is known as the MenACWY plain polysaccharide (ACWY Vax).” NCT00901940
Known as Control (Men ACWY) ClinicalTrials.gov intervention name — accepted as the source's own label NCT02324751
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, MenveoNCT04886154
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 “The comparator was (meningococcal [Groups A, C, W-135, and Y] oligosaccharide diphtheria CRM197 conjugate vaccine [Men ACWY]).” NCT03165617
13

NCT02140762

NCT03433482

NCT05919472

NCT04324606

NCT06213506

NCT02446691

NCT04056117

NCT03929757

NCT04536051

NCT02509494

NCT06523231

NCT02106390

NCT03587207

Known as MenACWY plain polysaccharide “The MenACWY Plain Polysaccharide Vaccine, which is already licensed and is used as a travel vaccine, is known as the MenACWY plain polysaccharide (ACWY Vax).” NCT00901940
Known as MenACWY vaccine ClinicalTrials.gov intervention name — accepted as the source's own label NCT06116669
1

NCT04707391

Known as MenACWY-CRM “This was the first study of laboratory workers who received both a conjugate vaccine against meningococcal serogroups A, C, W-135, and Y (Men ACWY-CRM, Menveo) and an...” PMID 21177912 Dec 2010
36

“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

MenACWY-CRM (Menveo®, Novartis Vaccines, Siena, Italy) is a quadrivalent meningococcal conjugate vaccine developed to help prevent invasive meningococcal disease caused by...” PMID 25075804 Jul 2014

“This study compares the safety and immunogenicity of the Novartis Vaccines investigational quadrivalent meningococcal CRM(197) conjugate vaccine, MenACWY-CRM, with the licensed...” PMID 19476428 Jul 2009

“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

“This study compared the investigational quadrivalent meningococcal CRM₁₉₇ conjugate vaccine, MenACWY-CRM, with licensed quadrivalent polysaccharide (MPSV4) and conjugate...” PMID 20655261 Jul 2010

“This phase III study assessed the immunogenicity and safety of MenACYW-TT in children compared with a licensed quadrivalent meningococcal vaccine conjugated with diphtheria...” PMID 32852352 Oct 2020

“A Phase 3, Multi-center, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Subjects From 2 to 75...” NCT01547715

“Infants were randomized 1:1 to receive MenACYW-TT (Group 1) or another quadrivalent conjugate vaccine, MenACWY-CRM (Group 2) at ages 6-7 and 12-13 months, co-administered with...” PMID 41792337 Mar 2026

“participants 10-25 years of age received 1 booster dose of MenABCWY vaccine at 24 months (M) postprimary series of MenABCWY (2 doses), 4CMenB (2 doses) or MenACWY-CRM vaccine (1 dose).” PMID 29329168 May 2018

“The quadrivalent meningococcal conjugate vaccine MenACWY-CRM has been shown to be immunogenic and well-tolerated in infants and toddlers.” PMID 31279564 Jul 2019

“Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)” NCT00329849

MenACWY-CRM (≥7-≤10 years of age)” NCT01823536

MenACWY-CRM (Novartis Vaccines)” PMID 20189491 Feb 2010

“Biological: MenACWY CRM” NCT00450437

NCT01593514

NCT01018732

NCT01000311

NCT01453348

NCT01424644

NCT00616421

NCT03135834

NCT00626327

NCT01345721

NCT00329901

NCT01766206

NCT01274897

NCT01682876

NCT03694405

NCT01214850

NCT01214837

NCT00488683

NCT00310856

NCT01994629

NCT01725217

NCT00262041

NCT04440163

Known as MenACWY-CRM197 “A quadrivalent meningococcal vaccine conjugated to CRM197 (MenACWY-CRM197) is immunogenic in young infants.” PMID 23566945 Apr 2013
Known as MenACWY-D “This study compared the investigational quadrivalent meningococcal CRM₁₉₇ conjugate vaccine, MenACWY-CRM, with licensed quadrivalent polysaccharide (MPSV4) and conjugate...” PMID 20655261 Jul 2010
Known as MenACWY-TT “Different fractional doses of two quadrivalent meningococcal conjugate vaccines (MenACWY-CRM197 (Menveo®) and MenACWY-TT (Nimenrix®)) were administered intradermally to...” PMID 29778515 May 2018
8

“We evaluated the bactericidal antibody persistence and safety of the quadrivalent meningococcal serogroups A, C, W and Y tetanus-toxoid conjugate vaccine (MenACWY-TT) and the...” PMID 26437712 Oct 2015

“a meningococcal A/C/W/Y tetanus toxoid conjugate vaccine (MenACWY-TT; Nimenrix®) in infants were evaluated.” PMID 39883399 Jan 2025

NCT05093829

NCT03189745

NCT03694405

NCT01192997

NCT05082285

NCT01994629

Known as MenACYW-135 conjugate vaccine ClinicalTrials.gov intervention name — accepted as the source's own label NCT03537508
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
5

“Biological: Meningococcal ACWY conjugate vaccine (MenACWY-CRM)” NCT00329901

Meningococcal ACWY Conjugate Vaccine, MenACWY” NCT02106390

NCT01547715

NCT00474487

NCT00474526

Known as meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent) ClinicalTrials.gov intervention name — accepted as the source's own label NCT02097849
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, NimenrixNCT02526394

“active control meningococcal vaccine (Nimenrix)” PMID 41652122 Feb 2026

NimenrixNCT04400838

NCT01144663

NCT04819113

NCT00514904

NCT00427908

NCT00715910

NCT07286370

NCT00465816

NCT00614614

NCT05743881

NCT04645966

NCT02548078

NCT01266993

NCT03606512

NCT01839175

Known as Nimenrix(Registered) “A PHASE IIIB, OPEN STUDY TO EVALUATE THE IMMUNOGENICITY, REACTOGENICITY AND SAFETY OF A BOOSTER DOSE OF MENACWY-TT VACCINE ADMINISTERED 10 YEARS AFTER HEALTHY SUBJECTS AGED...” NCT03189745
Known as Novartis MenACWY-CRM Novartis MenACWY-CRMNCT01274897
Known as Novartis Meningococcal ACWY Conjugate Vaccine “A Phase 3, Multi-center, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Children, Adolescents...” NCT01725217
1

Novartis Meningococcal ACWY Conjugate VaccineNCT01274897

Modality Vaccine “Meningococcal ACWY Conjugate VaccineNCT00262041
Route Intramuscular “administered by IM injection into the anterolateral area of the right thigh” NCT00310856