Drugs / rMenB+OMV NZ
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02446743 | Nov 2015 → Sep 2016 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-04-16 | GlaxoSmithKline | Regulatory GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate. |
| 2020-01-23 | GlaxoSmithKline | Results World’s first meningitis B national infant vaccination programme shows 75% drop in cases over three years gsk.com ↗
Even though the study did not find vaccination to reduce nasopharyngeal carriage of Neisseria meningitidis, there was a reduction in the number of cases. |
| 2018-06-27 | GlaxoSmithKline | Regulatory Infants may now be protected against Meningitis B with fewer doses, adding flexibility to vaccination schedules gsk.com ↗
Healthcare professionals now have more options to help protect infants from invasive meningococcal disease (IMD) caused by serogroup B, after European Commission approval of an alternative Bexsero (rDNA, component, adsorbed)1 immunisation schedule requiring one less injection. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-04-16 | GlaxoSmithKline | GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA gsk.com ↗ |
| 2020-01-23 | GlaxoSmithKline | World’s first meningitis B national infant vaccination programme shows 75% drop in cases over three years gsk.com ↗ |
| 2018-06-27 | GlaxoSmithKline | Infants may now be protected against Meningitis B with fewer doses, adding flexibility to vaccination schedules gsk.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rMenB+OMV NZ | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02446743 ↗ |
| Known as | 4CMenB | “Data on duration of protection against invasive meningococcal disease post-vaccination with the recombinant, 4-component, meningococcal serogroup B vaccine (4CMenB) are limited.” PMID 30691980 ↗ Jan 2019 |
| Modality | Vaccine | “recombinant, 4-component, meningococcal serogroup B vaccine (4CMenB)” PMID 30691980 ↗ Jan 2019 |
| Route | Intramuscular | “One dose of the vaccine administered intramuscularly in the deltoid area of the non-dominant arm.” NCT02446743 ↗ |