Safety and Immunogenicity of a Novel Quadrivalent Meningococcal CRM-conjugate Vaccine Given Concomitantly With Routine Vaccinations in Infants

Abstract

A 4-dose series of MenACWY-CRM was highly immunogenic and well tolerated in young infants, and it can be coadministered with routine infant vaccines. Substantial immunity was conferred after the first 3 doses administered at 2, 4, and 6 months of age.

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

“…Recent studies in this vulnerable population have demonstrated promising results for MenACWY-CRM as indicated by robust immune responses against serogroups A, C, W-135, and Y and a well-tolerated safety profile. [20][21][22][23] To incorporate new vaccines into routine childhood immunization schedules, evidence is required that vaccines can be given concomitantly without compromising their immune responses and reactogenicity and safety profiles.…”

Persistence of the immune response after MenACWY-CRM vaccination and response to a booster dose, in adolescents, children and infants

“…Geometric mean titers were also modest across serogroups. Similarly, by 6 months after a 3-dose series of MenACWY-CRM given at 2, 4 and 6 months of age in infants, 9,10 antibody titers declined to different degrees across serogroups, with more than half of the infants retaining antibody titers 8 against serogroups C, W and Y at 6 months after vaccination (Fig. 3).…”

“…Long-term safety assessments did not indicate any specific safety concern, across studies and age groups. 9,10,[13][14][15][16]18 MenACWY-CRM was also well-tolerated as a booster, with no difference in local or systemic reactogenicity compared to single-or multiple-dose primary vaccinations. 14,16,18 In the studies involving a booster vaccination (studies 3, 4 and 7), the most commonly reported local reaction after booster was pain at the injection site (or tenderness in infants), while the most commonly reported systemic reaction was irritability in infants, toddlers and young children, and headache in older children and adolescents.…”

“…[7][8][9][10] This review appraises data from 7 phase 3 and phase 4 studies, with the objective of providing an overview of antibody persistence following primary vaccination with MenACWY-CRM vaccine, and responses to booster doses of the vaccine. 9,10,[11][12][13][14][15][16][17][18][19] Only data pertaining to the recommended dose schedules of MenACWY-CRM in each age group is assessed here : a single dose in children 2-10 y of age, adolescents and adults; 4 doses at 2, 4, 6 and 12 months of age in infants; and 2 doses given to unvaccinated children between 7-23 months of age. All the studies included in this review were conducted in accordance with good clinical practice and International Conference on Harmonisation of Techniques for Requirements for Registration of Pharmaceuticals for Human Use guidelines, and were approved by Institutional Review Boards (IRBs) or Ethics Committees (ECs) in each country, as appropriate, prior to start of the study.…”

Meningococcal Disease and Quadrivalent MenACWY-CRM Vaccine (Menveo®)

“…MenACWY-CRM has been shown to be highly immunogenic and well tolerated in infants 52) , toddlers 53) , children 54,55) , adolescents 56,57) and adults 58) . For example, a phase 3 multicenter study conducted in 2180 adolescents (11)(12)(13)(14)(15)(16)(17)(18) .…”