TheraRadar
Data updated: May 26, 2026

Bexsero (meningococcal group b vaccine)

Approved 2015-01-22
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Prescription
First Approved
2015-01-22
Routes
Intramuscular
Dosage Forms
Injection

Companies

GSK
Active Ingredient: Meningococcal Group B Vaccine

Bexsero Approval History

2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2015 to 2015
Jan 2015 ORIGINAL
Update · CBER biologic (Purple Book)

What Bexsero Treats

1 FDA approvals

Originally approved for its first indication in 2015 .

  • Other (1)
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Clinical Trial Registry

13 trials
Trial Sponsor ID Phase Status Title
NCT06033261 results posted mRNA-1608-P101 Ph 1, Ph 2 completed 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
NCT04350138 19-0004 Ph 2 active not recruiting Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection
NCT05294588 21-0498 DMID 21-0018, U01AI162457-01 Ph 2 completed Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae
NCT06647407 VAN00013 2023-510465-10 Ph 1, Ph 2 active not recruiting Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants
NCT06128733 VAN00010 U1111-1272-6824, 2023-000924-13 Ph 1, Ph 2 completed Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents
NCT06446752 STUDY00019050 Ph 3 active not recruiting BIYELA - Bexsero Immunisation in Young Women in Africa
NCT06025487 MenB_Asplenia 2022-001451-16 Ph 2 recruiting Meningococcal B Vaccine in Patients with Asplenia
NCT04722003 results posted 19-0015 Ph 2 completed Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination
NCT04645966 results posted C3511002 2020-000948-60 Ph 2 terminated A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants
NCT03632720 results posted MET52 2017-004520-30, U1111-1183-6530 Ph 3 completed Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom
NCT04094883 4CMenB results posted 19-1145 Ph 4 completed Study to Assess Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine
NCT02212457 results posted 205215 V102_15, 2013-002451-15 Ph 2 completed Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents
NCT02491463 results posted 201974 Ph 1 completed A Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' RSV Investigational Vaccine (ChAd155-RSV) (GSK3389245A) in Healthy Adults
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

Bexsero FDA Label Details

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Data Sources

FDA Approval: BLA125546 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.