title: Safety of Quadrivalent Meningococcal Conjugate Vaccine in 11- to 21-Year-Olds.
abstract: Meningococcal conjugate vaccination is recommended in the United States. This study evaluates the safety of quadrivalent meningococcal conjugate vaccine in a cohort aged 11 to 21 years.
  
  
  
  This cohort study with self-controlled case-series analysis was conducted at Kaiser Permanente Southern California. Individuals receiving MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, during September 30, 2011 to June 30, 2013, were included. Twenty-six prespecified events of interest (EOIs), including neurologic, rheumatologic, hematologic, endocrine, renal, pediatric, and pediatric infectious disease EOIs, were identified through electronic health records 1 year after vaccination. Of these, 16 were reviewed by case review committees. Specific risk and comparison windows after vaccination were predefined for each EOI. The relative incidence (RI) and 95% confidence intervals (CIs) were estimated through conditional Poisson regression models, adjusted for seasonality.
  
  
  
  This study included 48 899 vaccinated individuals. No cases were observed in the risk window for 14 of 26 EOIs. The RI for Bell's palsy, a case review committee-reviewed EOI, was statistically significant (adjusted RI: 2.9, 95% CI: 1.1-7.5). Stratified analyses demonstrated an increased risk for Bell's palsy in subjects receiving concomitant vaccines (RI = 5.0, 95% CI = 1.4-17.8), and no increased risk for those without concomitant vaccine (RI = 1.1, 95% CI = 0.2-5.5).
  
  
  
  We observed a temporal association between occurrence of Bell's palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation as it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's palsy.
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California; hung-fu.x.tseng@kp.org.
authors.forename: Hung-Fu
authors.initials: HF
authors.lastname: Tseng
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.
authors.forename: Lina S
authors.initials: LS
authors.lastname: Sy
authors.affiliation: Pediatrics and Pediatric Infectious Diseases, Southern California Permanente Medical Group, Harbor City, California.
authors.forename: Bradley K
authors.initials: BK
authors.lastname: Ackerson
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.
authors.forename: Rulin C
authors.initials: RC
authors.lastname: Hechter
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.
authors.forename: Sara Y
authors.initials: SY
authors.lastname: Tartof
authors.affiliation: Seqirus Netherlands B.V., Amsterdam, Netherlands.
authors.forename: Mendel
authors.initials: M
authors.lastname: Haag
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Slezak
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.
authors.forename: Yi
authors.initials: Y
authors.lastname: Luo
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.
authors.forename: Christine A
authors.initials: CA
authors.lastname: Fischetti
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.
authors.forename: Harp S
authors.initials: HS
authors.lastname: Takhar
authors.affiliation: GlaxoSmithKline B.V., Amsterdam, Netherlands; and.
authors.forename: Yan
authors.initials: Y
authors.lastname: Miao
authors.affiliation: GlaxoSmithKline plc, London, United Kingdom.
authors.forename: Marianne
authors.initials: M
authors.lastname: Cunnington
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.
authors.forename: Zendi
authors.initials: Z
authors.lastname: Solano
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Jacobsen
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D020330:Bell Palsy / Q000209:etiology; D002140:California; D002648:Child; D015331:Cohort Studies; D057286:Electronic Health Records; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008585:Meningitis, Meningococcal / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*; D012307:Risk Factors; D055815:Young Adult
chemical_list: C556088:MenACWY-CRM vaccine; D022401:Meningococcal Vaccines