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.
Human vaccines & immunotherapeutics·
- DOI
- 10.1080/21645515.2026.2716508
- PMID
- 42642862
- PMCID
- —
- OpenAlex
- —
- Study type
- Randomised controlled trial
- Publisher
- Publisher unavailable
- Article type
- journal-article
- Integrity
- current
Why this research matters now
Establishing the safety of this vaccine when combined with routine pediatric immunizations aids regulatory approval and clinical administration guidelines. The data contributes to understanding potential interactions within standard infant vaccination protocols.
Structured evidence summary
Research question
This investigation assessed the safety profile of a specific quadrivalent meningococcal conjugate vaccine when used alongside standard childhood immunizations. The inquiry focused on comparing adverse event rates against an alternative licensed meningococcal product within a pediatric cohort.
Study design
The research utilized a Phase III randomized controlled trial design with an active comparator arm. Participants were allocated in a three-to-one ratio to receive either the investigational vaccine or the licensed reference product.
Population and setting
The study enrolled healthy infants and toddlers aged six weeks or older residing in the United States and Puerto Rico. Recruitment occurred across multiple sites participating in the four-dose vaccination schedule evaluation.
Main findings
Both vaccine groups demonstrated overall tolerability with similar rates of solicited local and systemic reactions. Serious adverse events and deaths were recorded but determined to be unrelated to the administered vaccines by investigators.
Public-health relevance
Establishing the safety of this vaccine when combined with routine pediatric immunizations aids regulatory approval and clinical administration guidelines. The data contributes to understanding potential interactions within standard infant vaccination protocols.
Important limitations
This summary relies exclusively on the provided abstract and metadata without access to the full manuscript or raw data. Consequently, detailed methodological nuances and complete statistical analyses remain unavailable for comprehensive evaluation.
GIDS interpretation
This document serves as a static record of published safety data regarding meningococcal vaccination strategies. It provides background context for literature reviews rather than indicating real-time monitoring signals or emerging trends.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 16 auditable classifier relationships to diseases, places, topics, and study design.