Drugs / MenABCWY
MenABCWY
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 | “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...” gsk.com ↗ |
| Filed | US (FDA) | — | meningococcemia | 2022-12-28 | “today announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for its investigational pentavalent meningococcal...” pfizer.com ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 28 trials · 2 met primary | ||||||
| Phase 2 | NCT05087056 | Nov 2021 → Mar 2027 expected | meningococcal meningitis | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04645966 | Nov 2020 → Sep 2022 | meningococcal infection | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT04440176 | Jun 2020 → Jan 2024 | meningococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT03587207 | Jul → Dec 2018 | meningococcal meningitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02212457 | Aug 2014 → May 2015 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02140762 | May → Nov 2014 | meningococcal infection | Novartis Vaccines | Completed | Met primary |
| Phase 2 | NCT01272180 | Aug → Oct 2011 | meningococcal infection | Novartis Vaccines | Completed | Met primary |
| Phase 2 | NCT01367158 | Jul 2011 → Jan 2012 | meningococcal meningitis | Novartis Vaccines | Completed | No outcome recorded |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT04502693 | Aug 2020 → Sep 2022 | meningococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT04440163 | Jun 2020 → Jul 2022 | meningococcal infection | Pfizer | Completed | Met primary |
| Phase 3 | NCT03135834 | Apr 2017 → Oct 2022 | meningococcal infection | Pfizer | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| 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. |
| 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. |
| 2023-05-12 | GlaxoSmithKline | Results GSK presents pivotal data at ESPID confirming effectiveness of its 5-in-1 meningococcal ABCWY vaccine candidate, with demonstrated coverage against a panel of 110 MenB strains gsk.com ↗
GSK plc (LSE/NYSE: GSK) today presented preliminary positive results from the phase III trial (NCT04502693) evaluating the immunological vaccine effectiveness and safety of its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years. |
| 2023-03-14 | GlaxoSmithKline | Results GSK announces positive pivotal phase III data for 5-in-1 Meningococcal ABCWY vaccine candidate gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced positive headline results from the phase III trial (NCT04502693) evaluating the safety, tolerability, and immunogenicity of its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years. |
| 2022-12-28 | Pfizer | Regulatory U.S. FDA Accepts for Review the Biologics License Application for Pfizer’s Investigational Pentavalent Meningococcal Vaccine Candidate (MenABCWY) in Adolescents pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for its investigational pentavalent meningococcal vaccine candidate (MenABCWY). |
| 2022-09-15 | Pfizer | Results Pfizer Announces Positive Top-Line Results from Phase 3 Trial of Pentavalent Meningococcal Vaccine Candidate (MenABCWY) in Adolescents pfizer.com ↗
The trial met all primary and secondary endpoints, with the investigational vaccine demonstrating non-inferiority to licensed vaccines for the five meningococcal serogroups that cause the majority of invasive meningococcal disease: serogroups A, B, C, W and Y. |
All press releases naming this drug 7 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MenABCWY | “A third MenABCWY vaccine dose induced robust immune responses against vaccine antigens, although antibody levels 6 months later were comparable with those observed 5 months...” PMID 26135245 ↗ Oct 201510“An investigational combined serogroups ABCWY vaccine (MenABCWY) was developed to protect against clinically important Neisseria meningitidis serogroups.” PMID 29329168 ↗ May 2018 |
| Known as | GSK3536819A | “The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A)...” NCT05087056 ↗1“of 2 doses of GSK's investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy adolescents and young adults.” NCT04502693 ↗ |
| Known as | PenbrayaTM | “pentavalent MenABCWY vaccine (PenbrayaTM)” PMID 42042828 ↗ Apr 2026 |
| Modality | Vaccine | “An investigational combined serogroups ABCWY vaccine (MenABCWY) was developed to protect against clinically important Neisseria meningitidis serogroups.” PMID 29329168 ↗ May 2018 |
| Route | Intramuscular | “0.5 mL MenABCWY vaccine (intramuscular (IM) injection)” NCT02140762 ↗ |