MenQuadfi (meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine) / Sanofi - LARVOL DELTA

Correction: Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study. (PubMed, Infect Dis Ther) - No abstract available

Clinical • P3 data • Infectious Disease • Meningococcal Infections

Penmenvy - a second pentavalent meningococcal vaccine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease • Meningococcal Infections

Study of a Novel Vaccine against Meningococcal Meningitis Compared with Locally Licensed Meningococcal Vaccines (clinicaltrialsregister.eu) - P1 | N=450 | Sponsor: Sanofi Pasteur Inc.

New P1 trial • CNS Disorders • Dermatology • Infectious Disease • Meningococcal Infections

Study of immunogenicity and safety of MenQuadfi® as a booster vaccine in toddlers 12 to 23 months, regardless of the quadrivalent meningococcal conjugate vaccine used for priming in infancy. (clinicaltrialsregister.eu) - P4 | N=180 | Sponsor: Sanofi Pasteur

New P4 trial • Dermatology • Infectious Disease • Meningococcal Infections

Five-Year Immune Persistence of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) and Immunogenicity and Safety of a Booster Dose in Children. (PubMed, Infect Dis Ther) - P3 | "MenACYW-TT provides long-term immune persistence and a robust immune response when administered as a booster in children primed 5 years earlier."

Journal • Infectious Disease • Meningococcal Infections • Tetanus

Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers (clinicaltrials.gov) - P3 | N=840 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2025 ➔ Oct 2025

Enrollment closed • Trial primary completion date • Infectious Disease • Meningococcal Infections

Quadrivalent meningococcal tetanus toxoid-conjugate booster vaccination in children aged 10-12 years: phase III randomized trial complementary analysis of immune persistence 3-6 years after priming. (PubMed, Pediatr Res) - "A MenACYW-TT booster induced a robust immune response; almost all participants achieved seroprotection against all serogroups. This analysis supports the ACIP recommendations for routine administration of a primary dose of a meningococcal ACWY conjugate vaccine at 11-12 years, with a booster dose at 16 years."

Journal • P3 data • Infectious Disease • Meningococcal Infections • Tetanus

Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (clinicaltrials.gov) - P1/2 | N=750 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Meningococcal Infections • Pediatrics

Analytical Challenges in Novel Pentavalent Meningococcal Conjugate Vaccine (A, C, Y, W, X). (PubMed, Vaccines (Basel)) - "Well-known meningococcal vaccines such as MenAfriVac, Nimenrix, Menveo, and MenQuadfi are licensed in various parts of the world and have been successful. Additional analytical challenges include the impact of excipients, potential interference from serogroups, selection and establishment of standards, age-dependent behavior of biomolecules indicated by molecular size distributions, and process-driven variations. This article explains the analytical insights gained (polysaccharide content, free saccharide, free proteins, MSD) during the development of the MenFive vaccine and highlights the crucial gaps and challenges in testing."

Journal • Review • CNS Disorders • Infectious Disease • Meningococcal Infections • Tetanus

Immune persistence and booster response of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) 5 years after primary vaccination of adults at ≥56 years of age. (PubMed, Hum Vaccin Immunother) - P3 | "Safety outcomes were similar between the two groups. A single booster dose of MenACYW-TT was well tolerated and immunogenic in older adults, with a higher immune response observed in those primed with MenACYW-TT."

Clinical • Journal • Infectious Disease • Meningococcal Infections • Tetanus

Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (clinicaltrials.gov) - P1/2 | N=750 | Not yet recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company

New P1/2 trial • Infectious Disease • Meningococcal Infections • Pediatrics

Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers (clinicaltrials.gov) - P3 | N=840 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Trial completion date: Mar 2025 ➔ Aug 2025

Trial completion date • Infectious Disease • Meningococcal Infections

Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers (IDWeek 2024) - No abstract available

Clinical • Infectious Disease • Meningococcal Infections

Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) when Co-administered with Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US and Puerto Rico (IDWeek 2024) - No abstract available

Clinical • Infectious Disease • Meningococcal Infections

Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy (clinicaltrials.gov) - P4 | N=71 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Completed | N=180 ➔ 71

Enrollment change • Trial completion • Infectious Disease • Meningococcal Infections

MEQ00064: Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa (clinicaltrials.gov) - P3 | N=1528 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Meningococcal Infections • Pediatrics

Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants (clinicaltrials.gov) - P1 | N=576 | Terminated | Sponsor: Sanofi Pasteur, a Sanofi Company | Phase classification: P1/2 ➔ P1

Phase classification • Infectious Disease • Meningococcal Infections

Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants (clinicaltrials.gov) - P1/2 | N=576 | Terminated | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Terminated; Sponsor decision. Termination decision not related to any safety concern.

Trial termination • Infectious Disease • Meningococcal Infections

Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents (clinicaltrials.gov) - P1/2 | N=1220 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Meningococcal Infections

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study. (PubMed, Infect Dis Ther) - P3 | "These data support the concomitant administration of MenACYW-TT with 9vHPV and Tdap-IPV vaccines in adolescents."

Clinical • Journal • P3 data • Infectious Disease • Meningococcal Infections • Tetanus

Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents (clinicaltrials.gov) - P1/2 | N=1220 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Initiation date: Jan 2023 ➔ Oct 2023

Trial initiation date • Infectious Disease • Meningococcal Infections

Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy (clinicaltrials.gov) - P4 | N=180 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Trial primary completion date: Apr 2024 ➔ Sep 2024

Trial primary completion date • Infectious Disease • Meningococcal Infections

Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents (clinicaltrials.gov) - P1/2 | N=1220 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Initiation date: Oct 2023 ➔ Jan 2023

Trial initiation date • Infectious Disease • Meningococcal Infections

Study on a MenACYW Conjugate Vaccine Administered as a Single Dose in Participants Aged 12 Months and Older in Vietnam (clinicaltrials.gov) - P3 | N=446 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Meningococcal Infections

Use of the Pfizer Pentavalent Meningococcal Vaccine Among Persons Aged ≥10 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023. (PubMed, MMWR Morb Mortal Wkly Rep) - "Two quadrivalent (serogroups A, C, W, and Y) meningococcal conjugate vaccines (MenACWY) (MenACWY-CRM [Menveo, GSK] and MenACWY-TT [MenQuadfi, Sanofi Pasteur]) and two serogroup B meningococcal vaccines (MenB) (MenB-4C [Bexsero, GSK] and MenB-FHbp [Trumenba, Pfizer Inc.]), are licensed and available in the United States and have been recommended by CDC's Advisory Committee on Immunization Practices (ACIP). Different manufacturers' serogroup B-containing vaccines are not interchangeable; therefore, when MenACWY-TT/MenB-FHbp is used, subsequent doses of MenB should be from the same manufacturer (Pfizer Inc.). This report summarizes evidence considered for these recommendations and provides clinical guidance for the use of MenACWY-TT/MenB-FHbp."

Journal • Immunology • Infectious Disease • Meningococcal Infections • Primary Immunodeficiency