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Vaccines, Conjugate / Quadrivalent Meningococcal Conjugate Vaccine / Meningococcal Infections · Journal article
Human Vaccines & Immunotherapeutics · August 25, 2026
Well-designed and adequately powered for the question it asks.
This Phase III trial demonstrates that MenACYW-TT, a tetanus toxoid-conjugate quadrivalent meningococcal vaccine, has a comparable safety profile to the licensed MenACWY-CRM vaccine when given concomitantly with routine pediatric vaccines in infants and toddlers aged ≥6 weeks. Solicited reactions and serious adverse events occurred at similar rates in both groups, with all serious events and deaths adjudicated as unrelated to vaccination.
Phase III, modified double-blind, randomized, parallel-group, active-controlled trial. Healthy infants and toddlers aged ≥6 weeks in the USA and Puerto Rico; setting not specified beyond geography.. Intervention: MenACYW-TT (quadrivalent meningococcal tetanus toxoid-conjugate vaccine) administered at 2, 4, 6, and 12 months of age concomitantly with routine pediatric vaccines. Compared with: MenACWY-CRM (licensed quadrivalent meningococcal oligosaccharide diphtheria CRM197-conjugate vaccine, Menveo) administered on the same schedule with the same concomitant vaccines. n = 2,777. USA and Puerto Rico.
Solicited injection site reactions: 84.9% in MenACYW-TT group versus 84.6% in MenACWY-CRM group Solicited systemic reactions: 87.1% in MenACYW-TT group versus 88.2% in MenACWY-CRM group Serious adverse events: 5.2% in MenACYW-TT group and 3.0% in MenACWY-CRM group
No confidence intervals or p-values provided for comparative safety analyses between groups Serious adverse events: 5.2% in MenACYW-TT group and 3.0% in MenACWY-CRM group
Clinicians should note that MenACYW-TT demonstrates safety comparable to MenACWY-CRM when co-administered with routine childhood vaccines. The slightly higher SAE and AESI rates in the MenACYW-TT group, with all events adjudicated as unrelated to vaccination, do not indicate a safety signal but warrant continued post-marketing surveillance.
Phase III randomized controlled trial with adequate sample size (2,777 participants) and active comparator, demonstrating comparable safety profiles between MenACYW-TT and MenACWY-CRM with systematic adverse event monitoring; rigorous design supports but does not alone change clinical practice.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should note that MenACYW-TT demonstrates safety comparable to MenACWY-CRM when co-administered with routine childhood vaccines. The slightly higher SAE and AESI rates in the MenACYW-TT group, with all events adjudicated as unrelated to vaccination, do not indicate a safety signal but warrant continued post-marketing surveillance.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.