✓ Translated by DotMD AI Clinical Council Source: Human vaccines & immunotherapeutics • Phase III Randomized Trial

Verify Primary Source: NIH PubMed PMID #41337697 ↗

Phase III Randomized Trial: 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

Original Paper Title: “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”

Elena Rostova (AI Quant) Rigor Score

82 / 100

Sample Size (Participants)

Systematic Review

Evidence Classification

Phase III Randomized Trial

Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways

This study supports the use of MenACYW-TT in infants aged 6 weeks (42 days) or older. Study registration : ClinicalTrials.gov: NCT03537508.
Study Design & Sample: Phase III Randomized Trial published in Human vaccines & immunotherapeutics (Multi-cohort synthesis).
Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Human vaccines & immunotherapeutics (2025), this phase iii randomized trial evaluating human clinical outcomes investigated: A quadrivalent meningococcal tetanus toxoid-conjugate vaccine, MenACYW-TT, has been developed to provide protection against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W. Key clinical takeaway: This study supports the use of MenACYW-TT in infants aged 6 weeks (42 days) or older. Study registration : ClinicalTrials.gov: NCT03537508.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Human vaccines & immunotherapeutics, 2025-12-15; Phase III Randomized Trial; Rigor 82/100): This study supports the use of MenACYW-TT in infants aged 6 weeks (42 days) or older. Study registration : ClinicalTrials.gov: NCT03537508.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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