Drugs / Bivalent rLP2086
Bivalent rLP2086
Trials 3 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT04645966 | Nov 2020 → Sep 2022 | meningococcal infection | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT02531698 | Aug 2015 → Mar 2017 | meningococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT01543087 | Sep 2012 → Jan 2018 | meningococcal infection | Pfizer | Completed | No outcome recorded |
Press releases naming this drug 11 releases
| Date | Issuer | Release |
|---|---|---|
| 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 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bivalent rLP2086 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01543087 ↗ |
| Known as | MenB-FHbp | “This study aimed to evaluate persistence of the immune response to the serogroup B meningococcal (MenB) vaccine MenB-FHbp (Trumenba®, Bivalent rLP2086) under two- and...” PMID 30770221 ↗ Feb 20191“The meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) is licensed for use in children aged 10 years or older for protection against invasive serogroup B...” PMID 36087588 ↗ Sep 2022 |
| Known as | Trumenba | “This study aimed to evaluate persistence of the immune response to the serogroup B meningococcal (MenB) vaccine MenB-FHbp (Trumenba®, Bivalent rLP2086) under two- and...” PMID 30770221 ↗ Feb 20191“Trumenba (half dose) - Meningococcal Group B vaccine” NCT04645966 ↗ |
| Modality | Vaccine | “the serogroup B meningococcal (MenB) vaccine MenB-FHbp” PMID 30770221 ↗ Feb 2019 |