40 completed, 6 recruiting, 4 active not recruiting, 2 terminated. 20 Phase 2, 15 Phase 3, 11 Phase 4, 8 Phase 1, 2 Not applicable.
Follow 4CMenB vaccine: new trials by email Literature Review of 4CMenB vaccine trials Research Report on 4CMenB vaccine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase I Clinical Trial to Assess the Safety and Immunogenicity of DX-104 Bexsero®, Group B Meningococcal OMV Vaccine - Neisseria Meningitidis Serogroup B | Phase 1 | Recruiting | Shanghai Yuguan Biotech Co., Ltd.（Delonix Bioworks) | 30 | 2026-03-20 | 2026-04-06 |
| Immunogenicity and Safety of MenB Vaccine in Pediatric Patients With Autoimmune Rheumatic Diseases Meningococcal B (Bexsero) - Autoimmune Rheumatologic Disease | Phase 4 | Recruiting | University of Sao Paulo General Hospital | 263 | 2026-02-19 | 2026-04-20 |
| A Phase 3 Study to Assess the Immune Response And Safety Of Rmenb+Omv Nz In Primed Healthy Participants (10 To 20 Years Old) rMenB+OMV NZ vaccine - Meningitis | Phase 3 | Completed | GlaxoSmithKline | 312 | 2025-07-07 | 2026-04-21 |
| Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons Serogroup B meningococal vaccine - Meningococcal Meningitis, Serogroup B, Transgender Persons | Phase 4 | Recruiting | University Ghent | 250 | 2025-01-31 | 2026-01-20 |
| Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants Pentavalent Meningococcal ABCYW vaccine, MenACYW conjugate vaccine, Meningococcal group B vaccine - Meningococcal Immunization, Healthy Volunteers | Phase 1 / Phase 2 | Active not recruiting | Sanofi Pasteur, a Sanofi Company | 750 | 2024-11-05 | 2026-01-20 |
| BIYELA - Bexsero Immunisation in Young Women in Africa Bexsero, Placebo - Gonorrhea, Gonorrhea of Pharynx | Phase 3 | Active not recruiting | University of Washington | 1100 | 2024-08-14 | 2025-07-10 |
| Meningococcal B Vaccine in Patients with Asplenia Bexsero - Splenectomy; Status | Phase 2 | Recruiting | Medical University of Vienna | 80 | 2024-03-12 | 2024-11-22 |
| Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents Pentavalent Meningococcal ABCYW vaccine, MenACYW conjugate vaccine, Meningococcal group B vaccine - Meningococcal Immunisation, Healthy Volunteers | Phase 1 / Phase 2 | Completed | Sanofi Pasteur, a Sanofi Company | 1215 | 2023-10-31 | 2026-01-13 |
| A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes mRNA-1608, BEXSERO - Genital Herpes | Phase 1 / Phase 2 | Completed | ModernaTX, Inc. | 303 | 2023-09-06 | 2026-05-08 |
| Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections 4CMenB vaccine, Placebo - Gonorrhea, Sexually Transmitted Infection | Phase 3 | Active not recruiting | Chinese University of Hong Kong | 150 | 2023-05-04 | 2026-03-19 |
| Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia. Trumenba®, Bexsero® - Splenectomy | Phase 3 | Recruiting | Assistance Publique - Hôpitaux de Paris | 84 | 2022-09-15 | 2025-11-20 |
| Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae Cefixime, Ceftriaxone, Ciprofloxacin - Gonorrhea Male | Phase 2 | Completed | University of North Carolina, Chapel Hill | 65 | 2022-04-18 | 2026-03-02 |
| A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants MenACWY-7B low dose vaccine, MenACWY-7B high dose vaccine, MenABCWY-1Gen vaccine - Infections, Meningococcal | Phase 2 | Completed | GlaxoSmithKline | 726 | 2021-11-29 | 2026-06-26 |
| Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination Meningococcal Group B Vaccine, Placebo - Gonorrhoea | Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 52 | 2021-11-01 | 2026-10-21 |
| Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men 4CMenB vaccine, Placebo - Neisseria Gonorrheae Infection | Phase 3 | Active not recruiting | Kirby Institute | 650 | 2021-07-08 | 2025-03-24 |
| A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults MenABCWY-2Gen low dose vaccine, MenABCWY-2Gen high dose vaccine, Placebo - Infections, Meningococcal | Phase 1 / Phase 2 | Completed | GlaxoSmithKline | 1440 | 2021-06-14 | 2025-05-31 |
| Gonococcal Vaccine Study in Key Populations in Kenya 4CMenB (Bexsero®) vaccine - Gonorrhea | Not applicable | Completed | University of Oxford | 50 | 2021-05-31 | 2022-04-14 |
| Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine, 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine - Hiv, Meningococcal Infections | Phase 4 | Recruiting | Thomas Benfield | 55 | 2021-04-28 | 2021-05-06 |
| Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants Multicomponent Meningococcal B Vaccine, Meningococcal Group B Vaccine MenB, Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed) - Meningococcal Immunisation, Healthy Volunteers | Phase 1 | Terminated | Sanofi Pasteur, a Sanofi Company | 576 | 2021-03-29 | 2025-10-10 |
| Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine MenABCWY vaccine, Placebo, MenACWY vaccine - Meningitis, Meningococcal | Phase 3 | Completed | GlaxoSmithKline | 1250 | 2021-01-25 | 2024-07-03 |
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Meningococcal Infections (24) · Meningitis (11) · Meningitis, Meningococcal (10) · Gonorrhea (7) · Acquired Immunodeficiency Syndrome (2) · Sexually Transmitted Diseases (2) · Central Nervous System Diseases (1) · Coitus (1) · Communicable Diseases (1) · HIV Infections (1) · Herpes Genitalis (1) · Nervous System Diseases (1) · Pneumococcal Infections (1) · Premature Birth (1) · Respiratory Syncytial Virus Infections (1)
GlaxoSmithKline (16) · Sanofi Pasteur, a Sanofi Company (5) · Novartis Vaccines (4) · University of Oxford (4) · Canadian Immunization Research Network (2) · National Institute of Allergy and Infectious Diseases (NIAID) (2) · St George's, University of London (2) · University of North Carolina, Chapel Hill (2) · Assistance Publique - Hôpitaux de Paris (1) · CHU de Quebec-Universite Laval (1) · Chinese University of Hong Kong (1) · Kirby Institute (1) · Medical University of Vienna (1) · ModernaTX, Inc. (1) · Novartis (1)
United States (17) · United Kingdom (12) · Australia (8) · Finland (7) · Canada (6) · Italy (6) · Poland (5) · Spain (5) · Brazil (4) · Czechia (4) · Germany (4) · Puerto Rico (4) · Argentina (3) · Turkey (Türkiye) (3) · Belgium (2)
Joseph A Duncan, MD, PhD (2) · Andrew J Pollard, PhD (1) · Catherine Cosgrove, MBBS PhD (1) · Connie Celum, MD, MPH (1) · Eduard Sanders, MD, PhD (1) · Gaston De Serres, MD, PhD (1) · Helen Marshall (1) · Joanne M Langley, MD, MSc, FRCPC (1) · Matthew D Snape (1) · Michaela Tinggaard, M.D. (1) · Nicole Harrison, Dr. (1)
PMID 33020485, PMID 10582782, PMID 17065257, PMID 1777459, PMID 19649242, PMID 20072772, PMID 20930072, PMID 21177912, PMID 21949601, PMID 22260988, PMID 22882265, PMID 25243015, PMID 25424810, PMID 25859659, PMID 26125141, PMID 26232542, PMID 27847367, PMID 28637733, PMID 29276051, PMID 30551148, PMID 31024540, PMID 31110098, PMID 31270173, PMID 31340042, PMID 31825501, PMID 31971677, PMID 32447370, PMID 32712083, PMID 33109390, PMID 33210468, PMID 33247553, PMID 33428870, PMID 33587122, PMID 33605081, PMID 34143779, PMID 34787449, PMID 35257644, PMID 35710444, PMID 35822945, PMID 36899125, PMID 37088964, PMID 37477875, PMID 38234190, PMID 38626958, PMID 38977298, PMID 39647494, PMID 39722560, PMID 40043411, PMID 40086037, PMID 40652683
2017 (4), 2019 (4), 2023 (4), 2016 (3), 2009 (1), 2014 (1), 2018 (1), 5UM1AI148576-05 (1), U01AI162457 (1)