Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe

Summary

Primary objective: This study aimed to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine was given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b \[DTaP-IPV-HB-Hib vaccine\]) to infants and toddlers 6 weeks to 18 months old Secondary objectives: This study aimed to demonstrate the non-inferiority of the antibody (Ab) response against meningococcal serogroups A, C, Y, and W following the administration of 2 doses in infancy of MenACYW conjugate vaccine compared to 2 doses of a licensed meningococcal vaccine when each vaccine was given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and DTaP-IPV-HB-Hib vaccine) to infants and toddlers 6 weeks to 18 months old. \- This study aimed to describe the Ab responses against meningococcal groups A, C, Y, and W and the antigens of the routine pediatric vaccines administered in the study.

Timeline

Start

2018-12-14

Primary completion

2023-05-17

Completion

2023-05-24

Outcome

Mixed primary results

paper Non-inferiority of MenACYW-TT versus MCV4-TT, based on GMTs post-booster, was demonstrated for serogroups C, W, and Y but not for A. PMID 40665158 ↗

Publications

• Martinon-Torres F, Virta MM, Koski S, de la Cueva IS, Szymanski HT, Bosis S, Draganescu AC, Silfverdal SA, Zambrano B, Dhingra MS, B'Chir S, Syrkina O, Lyabis O, Vasquez GA, Rehm C; MET58 Study Group. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered with Routine Pediatric Vaccines: A European Randomized Controlled Trial. Infect Dis Ther. 2025 Aug;14(8):1843-1865. doi: 10.1007/s40121-025-01190-7. Epub 2025 Jul 15.

Drugs

Indications