Drugs / Meningococcal Vaccine
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | meningococcemia | 2024-04-16 | “FDA has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate.” gsk.com ↗ |
| Filed | US (FDA) | — | meningococcemia | 2022-12-28 | “FDA accepted for review a Biologics License Application (BLA) for its investigational pentavalent meningococcal vaccine candidate (MenABCWY).” pfizer.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT03562377 | Jul 2018 → Sep 2019 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT01210885 | Dec 2010 → Jul 2011 | meningococcal meningitis | Novartis Vaccines | Completed | No outcome recorded |
| Phase 2 | NCT00126945 | Aug → Oct 2005 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00239694 | Apr 2001 → Aug 2012 | — | National Institute on Aging (NIA) | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT04704830 Background | Apr 2021 → Mar 2023 overdue | Plasmodium falciparum malaria | University of Oxford | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-04-16 | GlaxoSmithKline | Regulatory GSK’s 5-in-1 meningococcal vaccine Penmenvy receives positive recommendation from US Advisory Committee on Immunization Practices gsk.com ↗ |
| 2025-02-15 | GlaxoSmithKline | Regulatory Penmenvy, GSK’s 5-in-1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25 years. |
| 2022-10-17 | GlaxoSmithKline | Regulatory US FDA approves Menveo in a new single-vial presentation to help prevent disease caused by meningococcal bacteria serogroups A, C, Y, and W gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a new presentation of Menveo [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diptheria CRM197 Conjugate Vaccine] for individuals aged 10 to 55 years to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W. |
All press releases naming this drug 7 releases
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 | Meningococcal vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03562377 ↗ |
| Known as | MenABCWY | “MenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months.” NCT01210885 ↗ |
| Modality | Vaccine | “Meningococcal Conjugate Vaccine” NCT00126945 ↗ |
| Route | Intramuscular | “intramuscular (IM) administration” NCT01210885 ↗ |