Safety of Quadrivalent Meningococcal Conjugate Vaccine in 11- to 21-Year-Olds

Pediatrics. 2017 Jan;139(1):e20162084. doi: 10.1542/peds.2016-2084.


Background: 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.

Methods: 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.

Results: 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).

Conclusions: 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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adverse Drug Reaction Reporting Systems
  • Bell Palsy / etiology
  • California
  • Child
  • Cohort Studies
  • Electronic Health Records
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Meningitis, Meningococcal / prevention & control*
  • Meningococcal Vaccines / administration & dosage*
  • Meningococcal Vaccines / adverse effects*
  • Risk Factors
  • Young Adult


  • MenACWY-CRM vaccine
  • Meningococcal Vaccines