Drugs / MenACYW conjugate vaccine
MenACYW conjugate vaccine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | MenQuadfi | — | 2020-11-18 | europa.eu ↗ |
Trials 14 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06128733 | Oct 2023 → Aug 2025 | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT07710872 | Aug 2026 → Mar 2028 expected | meningococcal infection | Sanofi | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07135986 | Sep 2025 → May 2026 overdue | meningococcal infection | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05794230 | Mar 2023 → Nov 2025 | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT04490018 | Mar 2021 → May 2022 | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT04368429 | May → Nov 2020 | — | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT03890367 | Sep 2019 → Oct 2020 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT04084769 | Sep 2019 → Sep 2020 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT03547271 | Dec 2018 → May 2023 | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT03632720 | Oct 2018 → Dec 2022 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT03673462 | Sep 2018 → Mar 2023 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT03537508 | Apr 2018 → Sep 2023 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT03476135 | Feb → Sep 2018 | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05929651 | Sep 2023 → Sep 2024 | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06647407 Comparator | Nov 2024 → May 2027 expected | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06284915 Comparator | Mar 2024 → Nov 2025 | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-08-04 | Sanofi | Press Release: Sanofi’s MenQuadfi approved in the EU for use in infants from age six weeks against invasive meningococcal disease sanofi.com ↗ |
| 2021-07-10 | Sanofi | Media Update: MenQuadfi® demonstrates superior immune response against serogroup C meningococcal disease in toddlers sanofi.com ↗ |
| 2020-11-23 | Sanofi | European Commission approves MenQuadfi®, the latest innovation in meningococcal (MenACWY) vaccination for individuals 12 months of age and older sanofi.com ↗ |
| 2020-09-22 | Sanofi | CHMP recommends approval of MenQuadfi® for active immunization of individuals from the age of 12 months and older against invasive meningococcal ACWY disease sanofi.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MenACYW conjugate vaccine | “when MenACYW Conjugate vaccine was administered concomitantly with Bexsero® in the second year of life compared to when MenACYW Conjugate vaccine was given alone” NCT03632720 ↗12“evaluate and/or describe the immunogenicity and describe the safety of MenACYW conjugate vaccine when administered in infants and toddlers” NCT05794230 ↗ “received a single dose of MenACYW Conjugate vaccine on Day 0.” NCT03890367 ↗ |
| Known as | MenACYW conjugate vaccine - MenQuadfi | “MenACYW conjugate vaccine - MenQuadfi™” NCT05794230 ↗ |
| Known as | MenACYW-TT | “The immunogenicity and safety of MenACYW-TT (MenQuadfi®) were compared to another quadrivalent meningococcal conjugate vaccine, MCV4-TT (Nimenrix®), when administered in...” PMID 40665158 ↗ Jul 20253“A quadrivalent meningococcal tetanus toxoid-conjugate vaccine, MenACYW-TT, has been developed to provide protection against invasive meningococcal disease caused by Neisseria...” PMID 41337697 ↗ Dec 2025 “We compared the immune response of a tetanus toxoid conjugated quadrivalent meningococcal vaccine (MenACYW-TT, MenQuadfi®) with another quadrivalent meningococcal conjugate...” PMID 38955966 ↗ Jul 2024 “tetanus toxoid-conjugate quadrivalent meningococcal vaccine (MenACYW-TT)” PMID 36899125 ↗ Mar 2023 |
| Known as | Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine | “Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate Vaccine)” NCT04368429 ↗1“Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)” NCT03673462 ↗ |
| Known as | MenQuadFi | “Participants will receive MenACYW Conjugate Vaccine (MenQuadfi®): 2-dose schedule (1+1); dose 1 (priming dose) at 6-7 months of age and dose 2 (booster dose) at 12-13 months of...” NCT06284915 ↗ |
| Modality | Vaccine | “Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine” NCT03476135 ↗ |
| Route | Intramuscular | “intramuscular” NCT03476135 ↗ |