Nimenrix (MenACWY-TT) / Pfizer - LARVOL DELTA

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

Chikungunya: Dose-Response Phase 2 Safety and Immunogenicity Month 6 Data of VLA1553, a Single-Dose Live-Attenuated Vaccine in Children Aged 1 to 11 Years (ASTMH 2025) - P2 | "Among the 304 healthy children randomized 2:2:1 to a single shot of either the half or full dose VLA1553 formulation or control (Nimenrix®, tetravalent meningococcal vaccine), 7.9% had pre-existing CHIKV-specific antibodies. The Month 6 data confirm that the safety and tolerability profile was highly similar for VLA1553 full and half dose. The more pronounced immune response of the full compared to the half dose supports the use of the full dose moving forward."

Clinical • Late-breaking abstract • P2 data • Chikungunya • Infectious Disease • Meningococcal Infections

MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults (clinicaltrials.gov) - P4 | N=125 | Not yet recruiting | Sponsor: Emory University

New P4 trial

Investigating a Vaccine Against COVID-19 (clinicaltrials.gov) - P2/3 | N=10811 | Completed | Sponsor: University of Oxford | Active, not recruiting ➔ Completed | Trial completion date: Mar 2024 ➔ Feb 2025 | Trial primary completion date: Mar 2024 ➔ Feb 2025

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

mRNA-1365-P101: A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months (clinicaltrials.gov) - P1 | N=186 | Active, not recruiting | Sponsor: ModernaTX, Inc. | N=310 ➔ 186

Enrollment change • Respiratory Diseases

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

Public Health Impact of Potential Infant MenACWY Vaccination Strategies in Spain. (PubMed, Vaccines (Basel)) - "When strategies included a two-dose infant schedule, the earlier the infant MenACWY-TT vaccine was administered, the more additional cases, deaths, and cases with LTS were prevented (base-case and high-incidence scenarios). This analysis supports implementation of MenACWY-TT as a replacement for MenC vaccination."

Journal • Infectious Disease • Meningococcal Infections • Pediatrics • Tetanus

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

Immunogenicity of primary and booster MenACWY-TT vaccination in older adults and the importance of IgM. (PubMed, NPJ Vaccines) - "Interestingly, IgM depletion markedly reduced rSBA titers, while IgG depletion had minimal impact. These findings highlight that MenACWY-TT vaccination elicits functional antibody responses in older adults, largely driven by IgM."

Clinical • Journal • Infectious Disease • Meningococcal Infections

A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants (clinicaltrials.gov) - P2 | N=724 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • 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

Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine (clinicaltrials.gov) - P3 | N=1325 | Completed | Sponsor: Emory University | Active, not recruiting ➔ Completed | Trial completion date: Jul 2025 ➔ Feb 2025

Trial completion • Trial completion date • CNS Disorders • 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

Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine targeting serogroups A, C, W, Y, and X when co-administered with routine childhood vaccines at ages 9 months and 15 months in Mali: a single-centre, double-blind, randomised, controlled, phase 3, non-inferiority trial. (PubMed, Lancet) - P3 | "When compared with a licensed, quadrivalent meningococcal conjugate vaccine, and given alongside other routine vaccines, a single dose of NmCV-5 was safe and elicited a non-inferior immune response in infants aged 9 months and young children aged 15 months."

Head-to-Head • Journal • P3 data • CNS Disorders • Infectious Disease • Measles • Meningococcal Infections • Rubella

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

Safety, tolerability, and immunogenicity of pentavalent meningococcal MenABCWY vaccine in healthy infants: A phase 2b randomized clinical trial. (PubMed, Hum Vaccin Immunother) - "Immune responses for MenB test strains were higher with MenABCWY versus 4CMenB+MenACWY-TT and generally similar with 60 µg and 120 µg MenB-fHbp+MenACWY-TT or MenABCWY. Based on the limited results, the consistency of MenB immune responses with 60 µg and 120 µg MenB-fHbp suggests doses < 60 µg could be investigated to assess whether a more acceptable safety profile in conjunction with beneficial immune responses is possible in 2-month-old infants."

Clinical • Journal • P2b data • Infectious Disease • Meningococcal Infections • Pediatrics

A Phase 3B, Open-Label Study to Evaluate the Immunogenicity and Safety of the Quadrivalent Meningococcal Nimenrix® Vaccine When Given to Healthy Infants at 3 and 12 Months of Age. (PubMed, Infect Dis Ther) - P3 | "Nimenrix given at ages 3 and 12 months had a favorable safety profile and elicited protective immune responses and robust anamnestic booster responses across A/C/W/Y serogroups. These results provide important support for this alternative Nimenrix 1 + 1 immunization schedule for infants < 6 months, allowing flexibility in infant meningococcal immunization."

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

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

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

A Phase 1/2a Study Evaluating Safety and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers Aged 12-24 Months. (PubMed, Open Forum Infect Dis) - P1/2 | "In this randomized, observer-blinded, placebo-controlled, phase 1/2a study (NCT03606512; https://www.clinicaltrials.gov/ct2/show/NCT03606512), RSV-seronegative toddlers aged 12-24 months received Ad26.RSV.preF (2.5 × 1010 viral particles) or placebo on days 1, 29, and 57 (a meningococcal vaccine [Nimenrix] could substitute for day 57 placebo). At the final season 1 study visit, most Ad26.RSV.preF recipients had ≥2-fold increases from baseline in RSV-A2 neutralizing, RSV A and B preF binding, and RSV postF antibodies. Ad26.RSV.preF was well tolerated and immunogenic in RSV-seronegative toddlers."

Journal • P1/2 data • Infectious Disease • Meningococcal Infections • Otorhinolaryngology • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months (clinicaltrials.gov) - P1 | N=310 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Respiratory Diseases

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