Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines

Safety and immunogenicity of meningococcal ACWY CRM197-conjugate vaccine in children, adolescents and adults in Russia

“…Additionally, the majority of subjects (86% to 98% across serogroups) achieved hSBA titers ≥ 1:8 after 1 mo in our study, which is in accordance with the 75% and 99% range seen in the 3 earlier trials. 25,26,28 In the adults, our results are in agreement with previous trials conducted in the US 30 and Latin America. 32 The observed percentage of responders 1 mo post-vaccination in these 2 studies was between 50% and 86% across serogroups, 30,32 which is similar to the observed 57% and 85% in our study.…”

“…19,23 For the adolescent age subgroup (11 to 18 y), our results were similar to studies conducted in the US 25,26 and Costa Rica. 28 In these previous studies, the range of seroresponse in adolescent age groups ranged between 75% and 84%, 25,28 in our study it was between 82% to 89% for serogroups A, C, and Y, but was lower for serogroup W (51% vs. 75-81% in previous studies) 25,28 in accordance with the high baseline titer observed in the current study. Additionally, the majority of subjects (86% to 98% across serogroups) achieved hSBA titers ≥ 1:8 after 1 mo in our study, which is in accordance with the 75% and 99% range seen in the 3 earlier trials.…”

“…38 The safety and tolerability profile after MenACWY-CRM 197 vaccination was also similar to data previously reported by other studies, and comparable within the corresponding age subgroups. 2,19,23,25,26,28,29 Most of the solicited adverse events in our study were mild or moderate in intensity, and were resolved within 7 d of vaccination. There were no differences in the rates or type of local reactions across age groups; systemic reactions were observed in a similar proportion of children, adolescents, and adults (39% to 45%), and were less frequent among subjects 6 to 10 y of age (32%).…”

Immunogenicity and safety of a CRM-conjugated meningococcal ACWY vaccine administered concomitantly with routine vaccines starting at 2 months of age

“…11 MenACWY-CRM (Menveo ® , Novartis Vaccines and Diagnostics) is a quadrivalent (A, C, W-135, and Y) meningococcal vaccine conjugated to CRM 197 , a nontoxic mutant of diphtheria toxin, as the carrier protein. 12 Previous phase 2 and 3 studies demonstrated that MenACWY-CRM elicited highly immunogenic responses and was well-tolerated in adults, [13][14][15] adolescents, 13,16,17 children, 18,19 and importantly, young infants. Background: Infants are at the highest risk for meningococcal disease and a broadly protective and safe vaccine is an unmet need in this youngest population.…”

Adaptation of a previously validated vaccination report card for use in adult vaccine clinical trials to align with the 2007 FDA Toxicity Grading Scale Guidance

“…Two versions of the original VRC were created: a pediatric version for children 12 years of age and younger and an adult/adolescent version for individuals 13 years of age and older. Both VRC versions have been used in Merck clinical trials since 1998 [2][3][4][5][6][7][8][9][10] and have proven to be a useful method for identifying and characterizing injection site and other adverse experiences occurring after vaccination (e.g., temperature, medication use and administration of non-study vaccinations).…”