Bexsero
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Bexsero | — | 2013-01-13 | europa.eu ↗ |
Trials 42 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 | NCT06033261 | Sep 2023 → Apr 2025 | genital herpes | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT04886154 | Jun 2021 → Feb 2024 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/2 | NCT03636906 | Apr 2019 → Jan 2020 | respiratory syncytial virus infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT05294588 | Apr 2022 → Feb 2026 | gonorrhea | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2 | NCT04722003 | Nov 2021 → Oct 2023 | gonorrhea | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT04350138 | Dec 2020 → Feb 2026 overdue | gonorrhea | National Institute of Allergy and Infectious Diseases (NIAID) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04645966 | Nov 2020 → Sep 2022 | meningococcal infection | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT02482636 | Aug 2015 → Nov 2017 | infectious disease | University of Oxford | Completed | No outcome recorded |
| Phase 2 | NCT02212457 | Aug 2014 → May 2015 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00962624 | Jul 2010 → Mar 2011 | meningococcal meningitis | Public Health England | Completed | No outcome recorded |
| Phase 2 | NCT01027351 | Jan → Sep 2010 | meningococcal infection | Novartis Vaccines | Completed | No outcome recorded |
| Phase 2 | NCT00560313 | Jul 2007 → Nov 2009 | meningococcal infection | Novartis Vaccines | Completed | No outcome recorded |
| Phase 317 trials | ||||||
| Phase 3 | NCT06446752 | Aug 2024 → Oct 2026 expected | gonococcal cervicitis | University of Washington | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05766904 | May 2023 → Sep 2026 expected | gonorrhea | Chinese University of Hong Kong | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04166656 | Sep 2022 → Sep 2028 expected | — | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT04415424 | Jul 2021 → Jun 2025 overdue | gonorrhea | Kirby Institute | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04597424 | Jan 2021 → Feb 2023 | — | ANRS, Emerging Infectious Diseases | Completed | No outcome recorded |
| Phase 3 | NCT04318548 | Aug 2020 → Nov 2023 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT04084769 | Sep 2019 → Sep 2020 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT03632720 | Oct 2018 → Dec 2022 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT03621670 | Jul 2018 → Dec 2024 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02305446 | Dec 2014 → Apr 2015 | meningococcal meningitis | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT02173704 | Sep 2014 → Dec 2015 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01973218 | Nov 2013 → Apr 2014 | meningococcal infection | Novartis Vaccines | Completed | No outcome recorded |
| Phase 3 | NCT01894919 | Jun 2013 → Sep 2015 | meningococcal meningitis | Novartis Vaccines | Completed | No outcome recorded |
| Phase 3 | NCT01717638 | Nov 2012 → Sep 2013 | meningococcal meningitis | Novartis Vaccines | Completed | No outcome recorded |
| Phase 3 | NCT01423084 | Aug → Dec 2011 | meningococcal meningitis | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00847145 | Feb 2009 → Aug 2010 | meningococcal infection | Novartis Vaccines | Completed | No outcome recorded |
| Phase 3 | NCT00657709 | Mar 2008 → Jan 2010 | meningococcal meningitis | Novartis Vaccines | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT07252804 | Feb → Dec 2026 expected | autoimmune disease | University of Sao Paulo General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06832514 | Jan 2025 → Jul 2026 overdue | meningococcal meningitis | University Ghent | 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 | NCT04094883 | Oct 2019 → Sep 2020 | gonorrhea | University of North Carolina, Chapel Hill | Completed | 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 | NCT03125616 | Aug 2017 → Sep 2019 | meningococcal infection | St George's, University of London | Completed | No outcome recorded |
| Phase 4 | NCT02868970 | Feb 2017 → Jul 2021 | — | Canadian Immunization Research Network | Completed | No outcome recorded |
| Phase 4 | NCT02080559 | Jul 2014 → Jun 2016 | meningitis | University of Oxford | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT04297436 | May 2021 → Feb 2022 | gonorrhea | University of Oxford | Completed | No outcome recorded |
| — | NCT03509051 | Jun 2019 → Mar 2020 | disease related to hematopoietic stem cell transplant, meningococcal infection | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| — | NCT04515368 | Jun 2016 → Sep 2020 | — | Imperial College London | Completed | No outcome recorded |
| — | NCT02398396 | Apr → Nov 2015 | meningococcal infection | University of Oxford | Completed | No outcome recorded |
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07395739 Comparator | Mar 2026 → May 2027 expected | meningococcemia | Shanghai Yuguan Biotech Co., Ltd.（Delonix Bioworks) | Recruiting | No outcome recorded |
| Phase 1 | NCT04825223 Comparator | Mar 2021 → Jul 2022 | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Terminated | No outcome recorded |
| Phase 1 | NCT02491463 Comparator | Jul 2015 → Apr 2016 | respiratory syncytial virus infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06647407 Comparator | Nov 2024 → May 2027 expected | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Active not recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06025487 Comparator | Mar 2024 → Dec 2025 overdue | splenic disorder | Medical University of Vienna | Recruiting | No outcome recorded |
| Phase 2 | NCT01272180 Comparator | Aug → Oct 2011 | meningococcal infection | Novartis Vaccines | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04707391 Background | Jan 2021 → May 2023 | meningococcal meningitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT03089086 Comparator | Apr 2017 → Jul 2018 | meningococcal infection | University of Adelaide | Completed | No outcome recorded |
| Phase 4 | NCT02583412 Comparator | Sep 2015 → Sep 2016 | meningococcal infection | Canadian Immunization Research Network | Completed | No outcome recorded |
Press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-04-23 | Pfizer | Pfizer Granted FDA Breakthrough Therapy Designation for TRUMENBA® (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Children Ages 1 to 9 Years pfizer.com ↗ |
| 2017-12-13 | Pfizer | Phase 3 TRUMENBA® (Meningococcal Group B Vaccine) Data Published in New England Journal of Medicine Demonstrate the Vaccine’s Immunogenicity pfizer.com ↗ |
| 2016-10-19 | Pfizer | CDC Advisory Committee on Immunization Practices Votes to Recommend New Dosing Schedule for Vaccination with TRUMENBA® (Meningococcal Group B Vaccine) pfizer.com ↗ |
| 2016-05-20 | Pfizer | Pfizer Announces European Medicines Agency Acceptance for Review of Marketing Authorization Application for TRUMENBA® (Meningococcal Group B Vaccine) pfizer.com ↗ |
| 2016-05-13 | Pfizer | Pfizer Presents Results from Two Phase 3 TRUMENBA® (Meningococcal Group B Vaccine) Studies at the European Society for Paediatric Infectious Diseases Meeting pfizer.com ↗ |
| 2015-08-21 | Pfizer | Pfizer Announces Positive Topline Results Of Two Phase 3 Studies Of TRUMENBA® (Meningococcal Group B Vaccine) pfizer.com ↗ |
| 2015-02-24 | Pfizer | Pfizer Announces Positive Top-line Results Of A Phase 2 Study Of TRUMENBA® (Meningococcal Group B Vaccine) Co-Administered With Routine Meningococcal (A, C, Y, and W) And Tetanus, Diphtheria And Pertussis (Tdap) Vaccines In Adolescents pfizer.com ↗ |
| 2015-01-23 | Novartis Pharmaceuticals | Novartis Bexsero® vaccine approved by FDA for the prevention of meningitis B, a leading cause of bacterial meningitis in the US novartis.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 52 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bexsero | “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 ↗28“This study will investigate the breadth of protective activity of serum anti-FHbp antibody responses of adults immunized with 4CMenB (Bexsero®) vaccine as well as investigating...” NCT02398396 ↗ “The study intervention is vaccination with two doses of BEXSERO™ and two commercially available FDA-approved vaccines that do not have relevance to Neisseria gonorrhoeae:...” NCT05294588 ↗ “Here, we measured total IgG antibody binding profiles to a dedicated antigen microarray using human sera from an open-label Phase II trial (NCT00962624) of 4CMenB (Bexsero), a...” PMID 40043411 ↗ Mar 2025 “A Phase II Randomized, Observer-Blind, Placebo-Controlled Study, to Assess the Efficacy of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) in Preventing Gonococcal Infection” NCT04350138 ↗ “Bexsero is indicated for active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B.” NCT02868970 ↗ “Neisserial heparin-binding antigen (NHBA) is a surface-exposed lipoprotein from Neisseria meningitidis and is a component of the meningococcus B vaccine Bexsero.” PMID 28580917 ↗ May 2017 “Bexsero (Meningococcal group B subunit / Outer Membrane Vesicles, GlaxoSmithKline); 0.5 mL. intramuscular. stat.” NCT04515368 ↗ “One intramuscular injection of Bexsero (multicomponent B vaccine) from 6 months after transplant.” NCT03509051 ↗ “The 4CMenB vaccine (Bexsero®) induces antibodies in humans that recognise gonococcal proteins.” NCT04297436 ↗ “Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men” NCT04415424 ↗ “GSK's meningococcal group B vaccine, Bexsero” NCT04886154 ↗ “Bexsero®” NCT06128733 ↗ |
| Known as | 4-component Meningococcal B vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02482636 ↗ |
| Known as | 4CMenB | “Here, we measured total IgG antibody binding profiles to a dedicated antigen microarray using human sera from an open-label Phase II trial (NCT00962624) of 4CMenB (Bexsero), a...” PMID 40043411 ↗ Mar 202516“We assessed lot-to-lot consistency, safety and immunogenicity, and the effect of concomitant vaccination on responses to routine vaccines of an investigational multicomponent...” PMID 23324563 ↗ Mar 2013 “One schedule for the capsular group B meningococcal vaccine 4CMenB is 2 doses that are administered 2 months apart for children aged 12-23 months, with a booster dose 12-24...” PMID 29038320 ↗ Oct 2017 “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 multicomponent serogroup B meningococcal (4CMenB) vaccine induces antibodies against indicator strains of serogroup B meningococcus under various schedules.” PMID 25802309 ↗ Mar 2015 “Recently, a four-component recombinant vaccine (4CMenB) has been developed and is now approved in Europe, Canada, Australia and some Latin American countries.” PMID 26232542 ↗ Jul 2015 “assessed the immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in healthy Korean adolescents.” PMID 26826544 ↗ Jan 2016 “The meningococcal 4CMenB (Bexsero) vaccine (rMenB+OMV NZ), that targets serogroup B N. meningitidis” NCT06446752 ↗ “4-component Meningococcal B (4CMenB) vaccine IM 0.5ml given at 2, 4 and 12 months” NCT02482636 ↗ “multicomponent meningococcal serogroup B vaccine (4CMenB or Bexsero (R))” NCT04722003 ↗ |
| Known as | 4CMenB Vaccine | “Biological: 4CMenB Vaccine” NCT03125616 ↗ |
| Known as | Bexsero (R) | “multicomponent meningococcal serogroup B vaccine (4CMenB or Bexsero (R))” NCT04722003 ↗ |
| Known as | four component meningococcal B | “This multicomponent vaccine is also referred to as the "four component meningococcal B" or "4CMenB" vaccine.” NCT02398396 ↗ |
| Known as | GSK's meningococcal group B vaccine, Bexsero | “GSK's meningococcal group B vaccine, Bexsero” NCT04886154 ↗ |
| Known as | GSK's multicomponent meningococcal B vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03636906 ↗ |
| Known as | GSK3536829A | “Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ)” NCT04318548 ↗ |
| Known as | MenB vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04707391 ↗ |
| Known as | Meningococcal B | “Meningococcal B (Bexsero)” NCT07252804 ↗ |
| Known as | Meningococcal Group B Vaccine | “A Phase II Randomized, Observer-Blind, Placebo-Controlled Study, to Assess the Efficacy of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) in Preventing Gonococcal Infection” NCT04350138 ↗ |
| Known as | Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04825223 ↗ |
| Known as | rMenB+OMV NZ | “A Phase II Randomized, Observer-Blind, Placebo-Controlled Study, to Assess the Efficacy of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) in Preventing Gonococcal Infection” NCT04350138 ↗3“The meningococcal 4CMenB (Bexsero) vaccine (rMenB+OMV NZ), that targets serogroup B N. meningitidis” NCT06446752 ↗ “Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)” NCT03621670 ↗ “Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ)” NCT04318548 ↗ |
| Known as | Sanofi MenB | “Sanofi MenB” NCT06128733 ↗ |
| Known as | Serogroup B meningococal vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06832514 ↗ |
| Modality | Vaccine | “4CMenB is a multi-component vaccine against MenB” PMID 33020485 ↗ Oct 2020 |
| Route | Intramuscular | “0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose” NCT01717638 ↗ |