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serogroup b meningococcal vaccine

Trade name: Trumenba

VaccineapprovedBreakthrough Therapy FDA

Approved

Jun 14, 2012

Clinical trial activity

39 trials · 19 clinical orgs · 2 marketing orgs

Phase 1
7
Phase 2
30
Phase 3
13
Phase 4
5

Earliest trial started Feb 1, 2006 (NCT00297817)

Timeline

2000s

  1. Jan 1, 2006

    Pfizer — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2008

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jun 14, 2012

    GlaxoSmithKline — Earliest FDA Approval

  2. Jun 14, 2012

    GlaxoSmithKline — NDA Secondary Org

  3. Jun 14, 2012

    GlaxoSmithKline — NDA Organization

  4. Oct 29, 2014

    Pfizer — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedBreakthroughJun 14, 2012

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Also known as

  • bivalent rlp2086
  • meningococcal b vaccine
  • mnb rlp2086
  • mnb rlp8026
  • neisseria meningitidis serogroup b fhbp (recombinant lipidated fhbp (factor h binding protein)) subfamily a; neisseria meningitidis serogroup b fhbp (recombinant lipidated fhbp (factor h binding protein)) subfamily b
  • recombinant meningococcal b vaccine
  • rlp2086
  • serogroup b meningococcal vaccine
  • trumenba vaccine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07197762Phase 4Oct 31, 2025Emory University, Pfizer
NCT06647407Phase 1/Phase 2 (Phase 2)Oct 28, 2024Sanofi-Aventis
NCT06128733Phase 1/Phase 2 (Phase 2)Oct 31, 2023Sanofi, Sanofi-Aventis
NCT06314880Phase 1Jul 22, 2023Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
NCT05294588Phase 2Apr 18, 2022National Institute of Allergy and Infectious Diseases (NIAID), University of North Carolina at Chapel Hill
NCT04722003Phase 2Nov 1, 2021National Institute of Allergy and Infectious Diseases (NIAID)
NCT04893811Phase 4Aug 18, 2021Pfizer
NCT04825223Phase 1/Phase 2 (Phase 2)Mar 29, 2021Sanofi, Sanofi-Aventis
NCT04645966Phase 2Nov 24, 2020Pfizer
NCT04350138Phase 2Aug 6, 2020National Institute of Allergy and Infectious Diseases (NIAID)
NCT04440163Phase 3Jun 19, 2020Pfizer
NCT04318548Phase 3May 4, 2020GlaxoSmithKline
NCT04166656Phase 3Feb 29, 2020Assistance Publique - Hôpitaux de Paris, EUCLID, Innovative clinical research network in vaccinology (I-REIVAC), Institut Pasteur, University of Paris
NCT04094883Phase 4Sep 30, 2019University of North Carolina at Chapel Hill
NCT04084769Phase 3Sep 3, 2019Sanofi-Aventis
NCT03632720Phase 3Oct 31, 2018Sanofi-Aventis
NCT03135834Phase 3Apr 24, 2017Pfizer
NCT02868970Phase 4Feb 15, 2017Dalhousie University
NCT02534935Phase 2Aug 31, 2015Pfizer
NCT02531698Phase 2Aug 27, 2015Pfizer
Showing 20 of 39 trials
Page 1 / 2

Organizations

Research & Development (19)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PfizerFor profit191842006
NovartisFor profit5522006
Sanofi-AventisFor profit5522018
National Institute of Allergy and Infectious Diseases (NIAID)Government3212020
SanofiFor profit2012021
University of North Carolina at Chapel HillAcademic/Hospital2222019
WyethFor profit2012006
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.For profit1112023
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112020
Dalhousie UniversityAcademic/Hospital1112017
Emory UniversityAcademic/Hospital1112025
EUCLIDFor profit1012020
GlaxoSmithKlineFor profit1112020
Innovative clinical research network in vaccinology (I-REIVAC)Academic/Hospital1012020
Institut PasteurAcademic/Hospital1012020
Public Health EnglandGovernment1112006
University of California, San FranciscoAcademic/Hospital1112015
University of MassachusettsAcademic/Hospital1012015
University of ParisAcademic/Hospital1012020
19 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
GlaxoSmithKlineFor profitNDA2Jun 14, 2012
GlaxoSmithKlineFor profitNDAJun 14, 2012
PfizerFor profitNDA2Oct 29, 2014