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 et al.
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In 30 seconds
This Phase III randomized controlled trial evaluated the safety of the quadrivalent meningococcal conjugate vaccine MenACYW-TT in healthy infants and toddlers in the USA and Puerto Rico. The study found that MenACYW-TT had a comparable safety profile to the licensed MenACWY-CRM vaccine, with solicited injection site reactions occurring in 84.9% of participants receiving MenACYW-TT.
Key findings
- Solicited injection site reactions occurred in 84.9% of MenACYW-TT recipients and 84.6% of MenACWY-CRM recipients.
- Solicited systemic reactions were reported in 87.1% of Group 1 and 88.2% of Group 2.
- 5.2% of participants in Group 1 and 3.0% in Group 2 experienced at least one serious adverse event.
Why it matters
Understanding the safety profile of new vaccines is crucial for clinicians to make informed decisions about immunization schedules and to reassure parents regarding the safety of concomitant vaccinations in young children.