Drugs / Trumenba
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed group B streptococcal infection 1 milestone | |||||
| Filed | EU (EMA) | TRUMENBA | group B streptococcal infection | 2016-05-20 | “the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for TRUMENBA® (Meningococcal Group B Vaccine) for review.” pfizer.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Trumenba | — | 2017-05-24 | europa.eu ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| 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 |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2018-04-23 | Pfizer | Regulatory 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 ↗
Pfizer Inc. (NYSE: PFE ) today announced that TRUMENBA ® (Meningococcal Group B Vaccine) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis group B (MenB) in children ages 1 through 9 years. |
| 2017-12-13 | Pfizer | Results Phase 3 TRUMENBA® (Meningococcal Group B Vaccine) Data Published in New England Journal of Medicine Demonstrate the Vaccine’s Immunogenicity pfizer.com ↗
Data from both studies demonstrated that TRUMENBA, as a three-dose series, elicits a protective immune response against diverse meningococcal group B (MenB) strains representative of prevalent strains causing invasive disease in the United States and Europe. |
| 2017-05-30 | Pfizer | Regulatory European Commission Approves Pfizer’s TRUMENBA® to Help Prevent Meningococcal Group B Disease in Adolescents and Adults pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that the European Commission (EC) has approved TRUMENBA® (Meningococcal Group B Vaccine) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older. |
| 2017-03-24 | Pfizer | Regulatory Pfizer Receives Positive CHMP Opinion for TRUMENBA® for Prevention of Meningococcal Group B Disease pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that TRUMENBA® (Meningococcal Group B Vaccine) be granted marketing authorization in the European Union (EU) for active immunization of individuals 10 years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB). |
| 2016-10-19 | Pfizer | Regulatory CDC Advisory Committee on Immunization Practices Votes to Recommend New Dosing Schedule for Vaccination with TRUMENBA® (Meningococcal Group B Vaccine) pfizer.com ↗
This new recommendation enables flexible vaccination dosing intervals depending on one’s risk of exposure to MenB, which makes it easier for healthcare providers to help protect individuals from this uncommon but life-threatening disease. |
| 2016-05-20 | Pfizer | Regulatory Pfizer Announces European Medicines Agency Acceptance for Review of Marketing Authorization Application for TRUMENBA® (Meningococcal Group B Vaccine) pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for TRUMENBA® (Meningococcal Group B Vaccine) for review. |
| 2016-05-13 | Pfizer | Results Pfizer Presents Results from Two Phase 3 TRUMENBA® (Meningococcal Group B Vaccine) Studies at the European Society for Paediatric Infectious Diseases Meeting pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced results of two Phase 3 studies demonstrating the immunogenicity of TRUMENBA ® (Meningococcal Group B Vaccine) against invasive meningococcal B (MnB) strains representative of prevalent strains in the U.S. and Europe. |
| 2015-10-09 | Pfizer | Results 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 ↗
Data demonstrated that immune responses following TRUMENBA, MCV4 and Tdap vaccines given concomitantly were noninferior to immune responses to MCV4 and Tdap alone or TRUMENBA alone. |
| 2015-08-21 | Pfizer | Results Pfizer Announces Positive Topline Results Of Two Phase 3 Studies Of TRUMENBA® (Meningococcal Group B Vaccine) pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today positive topline results of two Phase 3 studies of TRUMENBA ® (Meningococcal Group B Vaccine). |
| 2015-06-24 | Pfizer | Regulatory 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 ↗
Specifically, the ACIP voted that a serogroup B meningococcal (MenB) vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease. |
| 2015-02-26 | Pfizer | Regulatory CDC Advisory Committee on Immunization Practices Votes to Recommend Serogroup B Meningococcal Disease Vaccination for Persons at Increased Risk pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend serogroup B meningococcal vaccination to help protect individuals at increased risk. |
| 2015-02-24 | Pfizer | Results 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 ↗
The study met its co-primary immunogenicity objectives regarding co-administration of TRUMENBA with MCV4 and Tdap vaccines. |
All press releases naming this drug 12 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trumenba | “Trumenba®” NCT06128733 ↗ |
| Known as | MenB-FHbp | “* MenB-FHbp (Trumenba, Pfizer)” NCT07197762 ↗ |
| Modality | Vaccine | “Meningococcal Group B vaccine (Trumenba®)” NCT04084769 ↗ |
| Route | Intramuscular | “Route of administration: IM” NCT04084769 ↗ |