Drugs / rLP2086
rLP2086
Trials 10 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 26 trials | ||||||
| Phase 2 | NCT02534935 | Aug 2015 → Aug 2017 | meningococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01768117 | Feb 2013 → Feb 2014 | meningococcal meningitis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01323270 | Mar 2011 → Oct 2012 | meningitis, meningococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00808028 | Feb 2009 → Mar 2014 | meningococcal meningitis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00798304 | Jan → Jun 2009 | meningococcal meningitis | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT00387725 | Nov 2006 → Jan 2008 | — | Pfizer | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT03135834 | Apr 2017 → Oct 2022 | meningococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01352845 | May 2013 → Feb 2015 | — | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01830855 | Apr 2013 → Apr 2015 | meningococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01352793 | Nov 2012 → Sep 2014 | meningococcal meningitis | Pfizer | Completed | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00879814 Comparator | Apr 2009 → Jul 2012 | meningococcal meningitis | Pfizer | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01461980 Comparator | Sep 2011 → May 2014 | meningococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01461993 Comparator | Sep 2011 → Jul 2013 | 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 6 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rLP2086 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00879814 ↗ |
| Known as | bivalent rLP2086 | “BACKGROUND: Bivalent rLP2086 is a recombinant factor H binding protein-based vaccine approved in the USA for prevention of meningococcal serogroup B disease in 10-25-year-olds.” PMID 27745812 ↗ Oct 2016 |
| Known as | MenB-FHbp | “The MenB-FHbp vaccine (Trumenba®) is licensed in various countries for the prevention of meningococcal serogroup B disease in individuals ≥ 10 years of age.” PMID 35164991 ↗ Feb 2022 |
| Known as | Trumenba | “The MenB-FHbp vaccine (Trumenba®) is licensed in various countries for the prevention of meningococcal serogroup B disease in individuals ≥ 10 years of age.” PMID 35164991 ↗ Feb 20221“Bivalent rLP2086 (Trumenba)” NCT03135834 ↗ |
| Modality | Vaccine | “rLP2086 Vaccine” NCT00387725 ↗ |
| Route | Intramuscular | “intra-muscular vaccine (solution)” NCT00879814 ↗ |