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

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

Author information

1
Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California; hung-fu.x.tseng@kp.org.
2
Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.
3
Pediatrics and Pediatric Infectious Diseases, Southern California Permanente Medical Group, Harbor City, California.
4
Seqirus Netherlands B.V., Amsterdam, Netherlands.
5
GlaxoSmithKline B.V., Amsterdam, Netherlands; and.
6
GlaxoSmithKline plc, London, United Kingdom.

Abstract

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.

PMID:
28025240
DOI:
10.1542/peds.2016-2084
[Indexed for MEDLINE]
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