Drugs / MenACYW conjugate vaccine
MenACYW conjugate vaccine
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 311 trials · 4 met primary | ||||||
| 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 | Met primary |
| Phase 3 | NCT04368429 | May → Nov 2020 | — | Sanofi | Completed | Met primary |
| Phase 3 | NCT03890367 | Sep 2019 → Oct 2020 | — | Sanofi Pasteur, a Sanofi Company | Completed | Met primary |
| 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 | Mixed |
| 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 | Met primary |
| 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 |
| Comparator or background therapy2 trials | ||||||
| Phase 1/2 | NCT06647407 Comparator | Nov 2024 → May 2027 expected | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06284915 Comparator | Mar 2024 → Nov 2025 | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-08-04 | Sanofi | Regulatory Press Release: Sanofi’s MenQuadfi approved in the EU for use in infants from age six weeks against invasive meningococcal disease sanofi.com ↗
Sanofi’s MenQuadfi approved in the EU for use in infants from age six weeks against invasive meningococcal disease |
| 2021-07-10 | Sanofi | Results Media Update: MenQuadfi® demonstrates superior immune response against serogroup C meningococcal disease in toddlers sanofi.com ↗
The Phase 3 study met all primary and secondary endpoints, demonstrating that MenQuadfi induced superior immune responses to serogroup C based on geometric mean antibody titers (GMTs*) compared to NeisVac-C - a standard-of-care vaccine - in healthy toddlers. |
| 2021-02-05 | Sanofi | Regulatory Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER sanofi.com ↗
The EC approved MenQuadfi ® for active immunization of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y, based upon results from a robust and comprehensive international clinical program, including seven pivotal Phase 2 and 3 randomized, active-controlled, multi-center studies. |
| 2020-11-23 | Sanofi | Regulatory European Commission approves MenQuadfi®, the latest innovation in meningococcal (MenACWY) vaccination for individuals 12 months of age and older sanofi.com ↗
The European Commission (EC) has approved MenQuadfi ® for active immunization of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y. |
| 2020-09-22 | Sanofi | Regulatory 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 ↗
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for MenQuadfi ® for active immunization of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y. |
| 2020-04-24 | Sanofi | Regulatory FDA approves MenQuadfiTM, the latest innovation in meningococcal (MenACWY) vaccination sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has approved a Biologics License Application for MenQuadfi TM Meningococcal (Groups A, C, Y, W) Conjugate Vaccine for the prevention of invasive meningococcal disease in persons 2 years of age and older. |
All press releases naming this drug 6 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 18 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 ↗13“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 ↗ |
| Modality | Vaccine | “Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine” NCT03476135 ↗ |
| Route | Intramuscular | “intramuscular” NCT03476135 ↗ |