PT  - JOURNAL ARTICLE
AU  - Tseng, Hung-Fu
AU  - Sy, Lina S.
AU  - Ackerson, Bradley K.
AU  - Hechter, Rulin C.
AU  - Tartof, Sara Y.
AU  - Haag, Mendel
AU  - Slezak, Jeffrey M.
AU  - Luo, Yi
AU  - Fischetti, Christine A.
AU  - Takhar, Harp S.
AU  - Miao, Yan
AU  - Cunnington, Marianne
AU  - Solano, Zendi
AU  - Jacobsen, Steven J.
TI  - Safety of Quadrivalent Meningococcal Conjugate Vaccine in 11- to 21-Year-Olds
AID  - 10.1542/peds.2016-2084
DP  - 2017 Jan 01
TA  - Pediatrics
PG  - e20162084
VI  - 139
IP  - 1
4099  - http://pediatrics.aappublications.org/content/139/1/e20162084.short
4100  - http://pediatrics.aappublications.org/content/139/1/e20162084.full
SO  - Pediatrics2017 Jan 01; 139
AB  - 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.