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

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

Enrollment closed • Infectious Disease • Meningococcal Infections • Pediatrics

Immunogenicity and Safety of Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Potential Hajj/Umrah Pilgrims Aged ≥ 56 Years: A Phase III, Open-Label Study. (PubMed, Infect Dis Ther) - P3 | "MenACYW-TT vaccine induced a robust immune response against all serogroups (per seroprotection rates and GMTs). A single dose of the vaccine demonstrated acceptable safety profile in potential pilgrims aged ≥ 56 years."

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

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 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Meningococcal Infections • Pediatrics

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China (clinicaltrials.gov) - P3 | N=1602 | Recruiting | Sponsor: Sanofi | Trial completion date: Jun 2026 ➔ Nov 2026 | Trial primary completion date: Jan 2026 ➔ Jun 2026

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

Use of the GSK MenACWY-CRM/MenB-4C Pentavalent Meningococcal Vaccine Among Persons Aged ≥10 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2025. (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]) are licensed for use in the United States and recommended by CDC's Advisory Committee on Immunization Practices (ACIP)...On February 14, 2025, the Food and Drug Administration licensed a second pentavalent MenABCWY vaccine (MenACWY-CRM/MenB-4C [Penmenvy, GSK]) for prevention of invasive disease caused by N. meningitidis serogroups A, B, C, W, and Y in persons aged 10-25 years, the same indication for which MenACWY-TT/MenB-FHbp is licensed...Different manufacturers' serogroup B-targeting vaccines are not interchangeable; therefore, when MenACWY-CRM/MenB-4C is used, MenB-4C should be used for the other MenB doses. This report summarizes evidence considered for these recommendations and provides clinical..."

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

Safety and immunogenicity of a 3-dose schedule of a quadrivalent meningococcal tetanus toxoid conjugate vaccine administered concomitantly with routine pediatric vaccines to infants and toddlers: A descriptive randomized study. (PubMed, Hum Vaccin Immunother) - P3 | "MenACYW-TT (MenQuadfi®), a quadrivalent meningococcal conjugate vaccine, is approved for use in individuals aged ≥12 months or ≥6 weeks depending on the country...MenACYW-TT demonstrated a safety profile generally comparable with that of MCV4-CRM when administered concomitantly with routine pediatric vaccines. The MenACYW-TT conjugate vaccine in a 2 + 1 schedule demonstrated an acceptable immunogenicity and safety profile."

Clinical • Journal • Infectious Disease • Meningococcal Infections • Pediatrics • Tetanus

Modelling the epidemiological impact and cost-effectiveness of possible changes to the meningococcal vaccination schedule for adolescents and young adults in the United States. (PubMed, BMC Public Health) - "Q-QB-B was the most cost-effective schedule. Scenarios replacing the MenACWY dose at age 16 years with MenABCWY were not cost-effective vs. Q-QB-B. While cost savings could result from eliminating the first MenACWY dose, this was estimated to result in increased IMD incidence with associated mortality and morbidity."

HEOR • Journal • Infectious Disease • Meningococcal Infections

A Phase 3 study to assess the safety and immunogenicity of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) co-administered with routine pediatric vaccines in healthy infants in the USA and Puerto Rico. (PubMed, Hum Vaccin Immunother) - P3 | "MenACYW-TT and MenACWY-CRM were overall well tolerated, and the safety profiles of these vaccines were comparable. This study supports the use of MenACYW-TT in infants aged 6 weeks (42 days) or older.Study registration: ClinicalTrials.gov: NCT03537508."

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

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

Trial completion • Infectious Disease • Meningococcal Infections

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China (clinicaltrials.gov) - P3 | N=1504 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • 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 | Phase classification: P1 ➔ P1/2

Phase classification • Infectious Disease • Meningococcal Infections

Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents (clinicaltrials.gov) - P1/2 | N=1215 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Meningococcal Infections

Study on a MenACYW Conjugate Vaccine administered as a single dose in participants aged 12 months and older in Vietnam (clinicaltrialsregister.eu) - P3 | N=446 | Sponsor: Sanofi Pasteur

New P3 trial • Dermatology • Infectious Disease • Meningococcal Infections

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China (clinicaltrials.gov) - P3 | N=1504 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Infectious Disease • Meningococcal Infections

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered with Routine Pediatric Vaccines: A European Randomized Controlled Trial. (PubMed, Infect Dis Ther) - P3 | "Consideration of all immunogenicity and safety data generated in this study supports the incorporation of MenACYW-TT into the routine childhood vaccination schedule as a 2 + 1 regimen starting at age 6 weeks."

Journal • CNS Disorders • Infectious Disease • Meningococcal Infections • Pediatrics • Pneumococcal Infections

Modeling antibody persistence after MenACYW-TT vaccination and comparative analysis with other quadrivalent meningococcal vaccines. (PubMed, Sci Rep) - "At 10 years post-vaccination, it predicted comparable or higher seroprotective immunopersistence for MenACYW-TT (titers ≥ 1:8 with hSBA) versus (1) MCV4-TT in toddlers (77% [95% CI 70-84] vs. 17% [6-31] for serogroup C, 67% [59-74] vs. 36% [20-53] for serogroup W); (2) MenACWY-CRM in adolescents/young adults (63% [55-71] vs. 40% [32-48] for serogroup C, 67% [59-74] vs. 57% [47-67] for serogroup W); and (3) MPSV4 in older adults (31% [23-39] vs. 22% [14-29] for serogroup C, 38% [31-46] vs. 20% [14-27] for serogroup W). In conclusion, our analysis indicated similar or higher immune persistence at 10 years for MenACYW-TT compared with other quadrivalent meningococcal vaccines, particularly for serogroups C and W."

Clinical • Journal • Infectious Disease • Meningococcal Infections

A new quadrivalent meningococcal tetanus toxoid conjugate vaccine: Menquadfi® (MENACWY-TT). (PubMed, Hum Vaccin Immunother) - "Real-world studies show high vaccine effectiveness and herd protection benefits. However, further research is needed to evaluate long-term immunity and efficacy in high-risk populations."

Journal • Review • Infectious Disease • Meningococcal Infections • Tetanus

MODELING THE LONG-TERM PERSISTENCE OF PROTECTIVE ANTIBODIES FOLLOWING QUADRIVALENT MENINGOCOCCAL CONJUGATE VACCINATION GIVEN TO TODDLERS AND ADOLESCENTS/YOUNG ADULTS (ESPID 2025) - "For the other serogroups, numerically higher or comparable seroprotection rates are predicted for MenACYW-TT versus the other MCV4 vaccines. Conclusions/Learning Points MenACYW-TT demonstrated similar or better immune persistence at 10 years compared to MCV4-TT and MCV4-CRM, particularly for serogroups C and W. These findings support the use of MenACYW-TT in routine vaccination schedules, including those for children, to ensure sustained protection against invasive meningococcal disease."

Clinical • Infectious Disease • Meningococcal Infections • Tetanus

Understanding the value of meningococcal vaccination for adolescents and young adults in the United States: insights from a steady-state modelling approach. (PubMed, BMC Public Health) - "The two doses of MenACWY that are currently recommended play a crucial role in reducing the burden of IMD and the first dose contributes significantly (≥ 90%) to this reduction. It is essential to take this finding into account when considering any updates to the adolescent meningococcal vaccination schedule in the United States."

Journal • Infectious Disease • Meningococcal Infections

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