Drugs / Trumenba

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Trumenba 2017-05-24 europa.eu

Trials 7 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT06128733 Oct 2023 → Aug 2025 meningococcal infection Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 33 trials
Phase 3 NCT04166656 Sep 2022 → Sep 2028 expected Assistance Publique - Hôpitaux de Paris Recruiting No outcome recorded
Phase 3 NCT04440163 Jun 2020 → Jul 2022 meningococcal infection Pfizer Completed No outcome recorded
Phase 3 NCT04084769 Sep 2019 → Sep 2020 Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 43 trials
Phase 4 NCT07197762 Nov 2025 → Dec 2026 expected meningococcal infection Emory University Recruiting No outcome recorded
Phase 4 NCT04893811 Aug 2021 → Sep 2023 meningococcal infection Pfizer Completed No outcome recorded
Phase 4 NCT02569632 Jan 2015 → Dec 2016 meningococcal infection UCSF Benioff Children's Hospital Oakland Completed No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT04825223 Comparator Mar 2021 → Jul 2022 meningococcal infection Sanofi Pasteur, a Sanofi Company Terminated No outcome recorded

Press releases naming this drug 11 releases

DateIssuerRelease
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
2017-05-30 Pfizer European Commission Approves Pfizer’s TRUMENBA® to Help Prevent Meningococcal Group B Disease in Adolescents and Adults pfizer.com
2017-03-24 Pfizer Pfizer Receives Positive CHMP Opinion for TRUMENBA® for Prevention of Meningococcal Group B Disease 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
2015-10-09 Pfizer Pfizer’s Phase 2 Study Demonstrates Safety, Tolerability and Immunogenicity of TRUMENBA® When Coadministered with Meningococcal A, C, Y and W-135 Polysaccharide Conjugate (MCV4) and Tetanus, Diphtheria and Pertussis (Tdap) Vaccines in Adolescents pfizer.com
2015-08-21 Pfizer Pfizer Announces Positive Topline Results Of Two Phase 3 Studies Of TRUMENBA® (Meningococcal Group B Vaccine) pfizer.com
2015-06-24 Pfizer CDC Advisory Committee on Immunization Practices Votes to Recommend Serogroup B Meningococcal Disease Vaccination including TRUMENBA® for Adolescents and Young Adults 16 through 23 Years of Age 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

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as Trumenba Trumenba®” NCT06128733
6

NCT02569632

NCT07197762

NCT04166656

NCT04440163

NCT04084769

NCT04893811

Known as MenB-FHbp “* MenB-FHbp (Trumenba, Pfizer)” NCT07197762
Known as Multicomponent Meningococcal B Vaccine ClinicalTrials.gov intervention name — accepted as the source's own label NCT04825223
Modality Vaccine “Meningococcal Group B vaccine (Trumenba®)” NCT04084769
Route Intramuscular “Route of administration: IM” NCT04084769