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

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China (clinicaltrials.gov) - P3 | N=4568 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Meningococcal Infections

Burden of Invasive Meningococcal Disease: Evolving Epidemiology and Implications for Prevention Policy. (PubMed, Infect Dis Ther) - "Additional country-specific studies were included to contextualize age-specific epidemiology and provide policy comparators. A life-course-based prevention framework integrating age-related vulnerability, severity, and evolving transmission dynamics is needed to mitigate the burden of IMD."

Journal • Review • Cognitive Disorders • Infectious Disease • Meningococcal Infections

Narrative review of the clinical safety of MenACYW-TT: a quadrivalent meningococcal vaccine conjugated to tetanus toxoid licensed in the US and abroad. (PubMed, Expert Rev Vaccines) - "Immunization remains an essential preventive strategy against the potentially life-threatening and life-altering consequences of invasive meningococcal disease. The favorable benefit-risk profile of MenACYW-TT reinforces the safety of licensed vaccines and can help to counter vaccine hesitancy."

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

Safety of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in USA and Puerto Rico: Results from a Phase III, randomized, active-controlled study. (PubMed, Hum Vaccin Immunother) - P3 | "All SAEs, AESIs, and deaths were unrelated to study vaccines. This study supports the safety profile of MenACYW-TT in infants and toddlers aged ≥ 6 weeks.Study registration: Clinicaltrials.gov: NCT03673462; EudraCT: 2019-004459-35."

Clinical • Journal • P3 data • Hepatitis B • Infectious Disease • Inflammation • Meningococcal Infections • Pediatrics • Rotavirus Infections • Tetanus • Varicella Zoster

Adult immunization. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Herpes Zoster • Infectious Disease • Inflammation • Influenza • Measles • Meningococcal Infections • Pertussis • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus • Varicella Zoster

Comparison chart: Some vaccines for adults. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Infectious Disease • Inflammation • Influenza • Measles • Meningococcal Infections • Pertussis • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus

Press Release: Sanofi’s MenQuadfi approved in the EU for use in infants from age six weeks against invasive meningococcal disease (GlobeNewswire) - "The EU approval is supported by comprehensive data from the MET58 pivotal clinical study, which evaluated the immunogenicity, safety, and tolerability of MenQuadfi in infants from six weeks of age."

EMA approval • Meningococcal Infections

Post Marketing Surveillance Study for MenQuadfi [Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine] Administered in Participants Aged 6 Weeks to 55 Years in Republic of Korea (clinicaltrials.gov) - P=N/A | N=706 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Meningococcal Infections

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China (clinicaltrials.gov) - P3 | N=4568 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Infectious Disease • Meningococcal Infections

Safety and immunogenicity of concomitant quadrivalent meningococcus ACYW-TT and meningococcus group B vaccines. (PubMed, NPJ Vaccines) - P3 | "Reactogenicity was consistent with the known profiles of both vaccines; one case of anaphylaxis related to MenACYW-TT was reported and resolved without sequelae. No new safety concerns were identified."

Journal • Infectious Disease • Meningococcal Infections

Post Marketing Surveillance Study for MenQuadfi® [Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine] Administered in Participants Aged 6 Weeks to 55 Years in Republic of Korea (clinicaltrials.gov) - P=N/A | N=706 | Not yet recruiting | Sponsor: Sanofi

New trial • Infectious Disease • Meningococcal Infections • Tetanus

Podcast: Immune Persistence After Primary Vaccination with MenQuadfi. (PubMed, Infect Dis Ther) - "Several quadrivalent conjugate vaccines (MenACWY), MenQuadfi®, Menveo®, and Nimenrix®, are available, which target the same four serogroups, but differ in antigen composition and carrier proteins. Overall, the evidence supports the use of MenQuadfi as a MenACWY option, including for children, to help provide and maintain protection against IMD in the years following primary vaccination.Podcast available for this article. Supplementary material 1 (MP2 156850 kb)."

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

EXPLORING THE SUPERIORITY OF MENACYW-TT COMPARED TO OTHER LICENSED MENINGOCOCCAL VACCINE ACROSS THE FOUR SEROGROUPS IN ADOLESCENTS– A POST-HOC ANALYSIS (ESPID 2026) - P3 | "Analyses used the per-protocol analysis set. Results Across post hoc exploratory analyses, superiority criteria based on the lower bound of the confidence intervals boundaries were met for GMTs and vaccine seroresponse for all serogroups and for seroprotection rate for serogroup C. Conclusions/Learning Points These post hoc exploratory analyses suggested a superior immune response of MenACYW-TT to MCV4-TT for serogroup A, C, W and Y in seroresponse rate and GMTs, strengthening our understanding of the vaccine's performance beyond non-inferiority."

Head-to-Head • Retrospective data • 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=1602 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Meningococcal Infections

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 | Recruiting ➔ Completed

Trial completion • Infectious Disease • Meningococcal Infections

Meningococcal quadrivalent ACYW-TT conjugated vaccine at 6-23 months: phase III study (US/Puerto Rico). (PubMed, Pediatr Res) - P3 | "When administered as a two-dose series (1 + 1 schedule), MenACYW-TT demonstrated comparable/higher immunogenicity to MenACWY-CRM (ages 6-7 and 12-13 months) and the safety profiles of these quadrivalent meningococcal vaccines were similar. MenACYW-TT was non-inferior to MenACWY-CRM in terms of seroresponse rates and proportion of participants with antibody titer ≥1:8 after a second dose at age 12-13 months. This phase III study is the first to confirm the safety and immunogenicity of MenACYW-TT in infants and supports its use as a two-dose series from 6 months of age."

Journal • P3 data • Infectious Disease • Meningococcal Infections • Pediatrics • 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 | 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