Abstract
Background: Menveo,® a new quadrivalent meningococcal conjugate vaccine against serogroups A, C, W-135 and Y was approved in the US and EU for persons 11- to 55-year-olds. Integrated immunogenicity data has not been presented.
Methods: Results of 4 phase 3 studies with shared inclusion/exclusion criteria and immunogenicity endpoints were evaluated. Studies compared Menveo® with previously licensed vaccines (Menactra,® Menomune®) and evaluated sequential or co-administration of licensed adolescent vaccines (Tdap and HPV). Primary immunogenicity evaluations made 28 or 30 days postvaccination used serum bactericidal assays using human complement (hSBA); statistical noninferiority criteria were predefined.
Results: Overall, 6752 adolescents and adults were randomized to receive study vaccines at clinical centers in the United States, Italy, and Costa Rica. Comparisons to previously licensed vaccines revealed at least noninferior immunogenicity, as assessed by seroresponse for all serogroups versus both comparators as well as statistically higher results for each serogroup in various studies and age groups. Results for percentages of participants with hSBA 3 1:8 and hSBA GMTs were supportive of seroresponse results, indicating noninferiority compared with previously licensed products. Results also supported the use of Menveo® concomitantly or sequentially with Tdap and HPV; hSBA findings were inconsistent with interference among the antigens included in co-administered or sequentially administered vaccines.
Conclusion: In a database of several thousand adolescents and adults, Menveo® induced significant immune responses, as assessed by hSBA, without evidence of clinically significant interference when co-administered with recommended adolescent vaccines. Responses to Menveo® were statistically non-inferior or higher compared with previously licensed comparators.
Article PDF
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Dull, P., Gill, C., Karsten, A. et al. 535 Immunogenicity Profile of Menveo® in Adolescents and Adults Enrolled in Phase III Clinical Trials. Pediatr Res 68 (Suppl 1), 273–274 (2010). https://doi.org/10.1203/00006450-201011001-00535
Issue Date:
DOI: https://doi.org/10.1203/00006450-201011001-00535