Drugs / MenB-FHbp
MenB-FHbp
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00780806 | Oct 2008 → May 2010 | meningococcal meningitis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT01299480 | Mar 2011 → May 2012 | meningococcal infection | Pfizer | Completed | Met primary |
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 ↗
The CHMP’s opinion will now be sent to the European Commission (EC) for final decision. |
| 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 ↗
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend that: |
| 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. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MenB-FHbp | “The MenB-FHbp vaccine (Trumenba®) is licensed in various countries” PMID 35164991 ↗ Feb 2022 |
| Known as | rLP2086 | “A recombinant factor H binding protein (fHBP) vaccine (Trumenba(®); bivalent rLP2086) was recently approved in the United States in individuals aged 10-25 years.” PMID 26407272 ↗ Aug 2015 |
| Known as | Trumenba | “The MenB-FHbp vaccine (Trumenba®) is licensed in various countries” PMID 35164991 ↗ Feb 2022 |
| Modality | Vaccine | “A bivalent rLP2086 vaccine” PMID 23352429 ↗ Jan 2013 |