Observational Safety Study of Meningococcal Conjugate Vaccine Against Serogroups A, C, W and Y (Menactra) Used in Routine Healthcare Practice for Persons Aged 2 to 55 Years in Russian Federation

Abstract

Although incidence of invasive meningococcal disease (IMD) in the Russian Federation is low, children younger 15 years of age are significantly affected. Serogroups A, B, and C are frequently implicated. The quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) is approved in Russia for immunization of individuals 9 months to 55 years of age. Goals . We evaluated the safety of a single dose of MenACWY-D administered to individuals 2–55 years of age in routine clinical practice in the Russian Federation. Materials and Methods . Using diary cards filled by participants or their parents, this prospective multicenter observational study quantified the occurrence of solicited injection site and systemic reactions up to 7 days after vaccination as well as unsolicited non-serious adverse events (AEs), and serious adverse events (SAEs) for 28 days. Results . The systemicrate of solicited injection site and systemic reactions during the 7-day observation period was 52.0% (95% CI: 41.8; 62.2). Rates of solicited injection site reactions and systemic reactions of any severity were 49% (95% CI: 38.9; 59.2) and 20% (95% CI: 12.7; 29.2), respectively. The rate of unsolicited AEs was 9% (95% CI: 4.2; 16.4). Rates of solicited grade 3 injection site and systemic reactions ranged between 1–3% and 0–1%, respectively. There were no unsolicited adverse reactions (ARs), SAEs, or deaths. Conclusions . These findings corroborate those of pre-licensure and post-registration studies and confirm the safety and good tolerability of MenACWY-D when used in routine clinical practice in individuals 2–55 years of age in the Russian Federation.