Abstract
Background: Safety information about Menveo,® a novel quadrivalent meningococcal conjugate vaccine against serogroups A, C, W-135 and Y, was collected during the clinical development program. An integrated summary of safety data has not been previously presented.
Methods: Five randomized controlled studies that shared similar inclusion/exclusion criteria and safety and tolerability endpoints were evaluated to provide a clinical picture of the safety of Menveo, which was then compared with that of two previously licensed vaccines (Menactra® and Menomune®) in the context of sequential or co-administration with licensed routine adolescent vaccines (Tdap and HPV). Solicited injection site and systemic reactions were recorded for 7 days postvaccination; adverse events were monitored for at least six months after vaccination.
Results: A total of 6752 adolescents and adults enrolled in clinical trials and received study vaccines at clinical centers in the United States, Italy, and Latin America. Similar patterns of solicited reactions were observed in Menveo® and comparator meningococcal vaccine recipients. Safety results were consistent for Menveo® whether it was administered concomitantly or sequentially with Tdap and HPV without evidence of enhanced local reactogenicity. No consistent, unanticipated patterns were observed in adverse event profiles in the any of the clinical trials. As anticipated, serious adverse events were rare in these participants.
Conclusion: In a database of several thousand adolescents and adults, Menveo® was generally well tolerated without evidence of increased reactogenicity or clinically significant patterns of medical consequence when co-administered with recommended adolescent vaccines.
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Dull, P., Gill, C., Webster, C. et al. 532 Safety Profile of Menveo® in Adolescents and Adults Enrolled in Phase Iii Clinical Trials. Pediatr Res 68 (Suppl 1), 272 (2010). https://doi.org/10.1203/00006450-201011001-00532
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DOI: https://doi.org/10.1203/00006450-201011001-00532