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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.

Abraham Moskow·Sandeep Gupta·Mandeep Singh Dhingra·Betzana Zambrano·Lucia Gan·Siham B'Chir·Olga Syrkina·Audrey Hagenbach·Olga Lyabis·Christine Rehm
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Abstract

MenACYW-TT, a quadrivalent meningococcal tetanus toxoid-conjugate vaccine, is approved for prevention of invasive meningococcal disease in infants ≥ 6 weeks of age in the USA. This Phase III study (NCT03673462; September 17, 2018 - March 16, 2023) evaluated the safety of MenACYW-TT compared with a licensed quadrivalent meningococcal oligosaccharide diphtheria CRM197-conjugate vaccine (MenACWY-CRM) when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in a four-dose series (3+1 schedule). Participants were randomized 3:1 to receive MenACYW-TT (Group 1; n = 2080) or MenACWY-CRM (Group 2; n = 697) at 2, 4, 6, and 12 months of age, with concomitant administration of routine pediatric vaccines (DTaP5-IPV/Hib, PCV13, rotavirus, hepatitis B, MMR, and varicella vaccines). Safety assessments included immediate unsolicited adverse events within 30 minutes post-vaccination, solicited injection site and systemic reactions within 7d, unsolicited AEs within 30d, serious adverse events (SAEs) including adverse events of special interest (AESIs), and medically attended adverse events (MAAEs) throughout the study. MenACYW-TT and MenACWY-CRM were overall well tolerated, and safety profiles were comparable. Solicited injection site reactions occurred in 84.9% and 84.6% of participants in Groups 1 and 2, respectively; solicited systemic reactions in 87.1% and 88.2%, respectively. During the entire study, 5.2% in Group 1 and 3.0% in Group 2 experienced at least one SAE; 0.9% and 0.1%, respectively, reported at least one AESI. Three deaths occurred in Group 1. 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.

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Child, PreschoolFemaleHumansInfantMaleDiphtheria-Tetanus-Pertussis VaccineDrug-Related Side Effects and Adverse ReactionsImmunization ScheduleMeningococcal InfectionsMeningococcal VaccinesPuerto RicoUnited StatesVaccines, ConjugateMenACYW-TTQuadrivalent meningococcal conjugate vaccineinfantsinvasive meningococcal diseaseroutine pediatric vaccinessafetytoddlersJournal ArticleClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study

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Abraham Moskow, Sandeep Gupta, Mandeep Singh Dhingra, Betzana Zambrano, Lucia Gan, Siham B'Chir, Olga Syrkina, Audrey Hagenbach, Olga Lyabis, Christine Rehm. 2026-08-25. 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.. https://doi.org/10.1080/21645515.2026.2716508

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Child, Preschool subjectClinical Trial, Phase III subjectDiphtheria-Tetanus-Pertussis Vaccine subjectDrug-Related Side Effects and Adverse Reactions subjectFemale subjectHumans subjectImmunization Schedule subjectInfant subjectJournal Article subjectJournal Article; Clinical Trial, Phase III; Randomized Controlled Trial; Multicenter Study resourceMale subjectMenACYW-TT subjectMeningococcal Infections subjectMeningococcal Vaccines subjectMulticenter Study subjectRandomized controlled trials study

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