Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) in infants and children

• Published in: Vaccine 2018-04, Vol.36 (16), p.2133-2138
• Main Authors: Hansen, J., Zhang, L., Eaton, A., Baxter, R., Robertson, C.A., Decker, M.D., Greenberg, D.P., Bassily, E., Klein, N.P.
• Format: Article
• Language: English
• Subjects: Age; Age groups; Autoimmune diseases; Cellulitis; Children; Diphtheria; Disease control; Disease prevention; Drug dosages; Emergency medical services; Fever; Guillain-Barre syndrome; HIV; Human immunodeficiency virus; Hypersensitivity; Immunization; Infants; Influenza; Licenses; Meningitis; Meningococcal disease; Meningococcal infections; Meningococcal vaccines; Pediatrics; Population; Regression analysis; Risk management; Safety; Surveillance; Vaccination; Vaccines
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2018.02.107

Menactra® vaccine (MenACWY-D) was licensed in the United States in 2005 for persons 11–55 years of age, in 2007 for children 2–10 years of age, and in 2011 for infants/toddlers 9–23 months of age. We conducted two studies at Kaiser Permanente Northern California (KPNC), an integrated health care organization, to assess the safety of MenACWY-D in 2–10-year-olds and 9–23-month-olds receiving the vaccine during routine clinical care. We conducted observational, retrospective studies of MenACWY-D in 2–10-year-olds (October 2007–October 2010) and in 9–23-month-olds (June 2011–June 2014). We monitored all subjects for non-elective hospitalizations, emergency department visits, and selected outpatient outcomes (specified neurological conditions, hypersensitivity reactions and new-onset autoimmune diseases) up to 6 months after vaccination, depending on the study. Using a self-control risk-interval design, we calculated incidence rate ratios (IRRs) comparing outcomes during the post-vaccination risk interval (0–30 days) with those during more remote post-vaccination comparison intervals (31–60 and 31–180 days [children] or 31–75 days [infants/toddlers]). There were 1421 children aged 2–10 years and 116 infants/toddlers aged 9–23 months who received MenACWY-D. Approximately 30% of the 2–10-year-olds and 67% of the 9–23-month-olds were considered at increased risk of meningococcal disease. Among 2–10-year-olds, there was 1 hospitalization on post-vaccination day 5 for fever, which was considered possibly related to vaccination. The only significantly elevated outcome among 2–10-year-olds was cellulitis/abscess (2 cases occurred during the risk interval versus 0 during comparison interval; IRR not evaluable [NE], 95% CI: 1.42, NE). After medical record review, the 2 cases were considered unrelated to vaccination. Among 9–23-month-olds, no outcomes were significantly elevated after vaccination and there were no hospitalizations. There were no deaths observed during the three-year accrual and subsequent six-month surveillance period for either study. Immunization of infants and young children with MenACWY-D vaccine was not associated with any new safety concerns; however, these small studies had limited power to detect rare or uncommon safety events. ClinicalTrials.gov Identifiers are NCT00728260 and NCT01689155.