TheraRadar
Data updated: May 26, 2026

Trumenba (meningococcal group b vaccine)

Approved 2014-10-28
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Prescription
First Approved
2014-10-28
Patent Cliff
2026

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Routes
Intramuscular
Dosage Forms
Injection

Companies

Pfizer
Active Ingredient: Meningococcal Group B Vaccine

Trumenba Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2014 to 2014
Oct 2014 ORIGINAL
Update · CBER biologic (Purple Book)

What Trumenba Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • Other (1)
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Clinical Trial Registry

10 trials
Trial Sponsor ID Phase Status Title
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
NCT07197762 STUDY00009836 2025P011916 Ph 4 recruiting MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults
NCT04722003 results posted 19-0015 Ph 2 completed Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination
NCT04893811 results posted B1971060 2018-002588-24 Ph 4 completed Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age
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
NCT04440163 results posted C3511001 2019-004313-13 Ph 3 completed MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age
NCT04094883 4CMenB results posted 19-1145 Ph 4 completed Study to Assess Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine
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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.

Trumenba FDA Label Details

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Data Sources

FDA Approval: BLA125549 → Trials: ClinicalTrials.gov →

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