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. 2017 Aug-Sep;65(6):380-388.
doi: 10.1080/07448481.2017.1312418. Epub 2017 May 8.

Safety of a meningococcal group B vaccine used in response to two university outbreaks

Jonathan Duffy  1 , Peter Johnsen  2 , Mary Ferris  3 , Mary Miller  3 , Kevin Leighton  2 , Mark McGilvray  3 , Lucy McNamara  4 , Lucy Breakwell  4 , Yon Yu  5 , Tina Bhavsar  5 , Elizabeth Briere  4 , Manisha Patel  4
Affiliations

Safety of a meningococcal group B vaccine used in response to two university outbreaks

Jonathan Duffy et al. J Am Coll Health. 2017 Aug-Sep.

Abstract

Objective: To assess the safety of meningococcal group B (MenB)-4C vaccine.

Participants: Undergraduates, dormitory residents, and persons with high-risk medical conditions received the MenB-4C vaccine two-dose series during mass vaccination clinics from 12/2013 through 11/2014.

Methods: Adverse events (AEs) were identified by 15 minutes of observation postvaccination, spontaneous reports, surveys, and hospital surveillance. Causality was assessed for serious adverse events (SAEs).

Results: 16,974 persons received 31,313 MenB-4C doses. The incidence of syncope during the 15-minutes post-dose 1 was 0.88/1000 persons. 2% of participants spontaneously reported an AE (most common were arm pain and fever). 3 SAEs were suspected of being caused by the vaccine, including one case of anaphylaxis.

Conclusions: Most AEs reported were nonserious and consistent with previous clinical trial findings. Measures to prevent injury from syncope and to treat anaphylaxis should be available wherever vaccines are administered. Our safety evaluation supports the use of MenB-4C in response to outbreaks.

Keywords: Latex hypersensitivity; Neisseria meningitidis serogroup B; meningococcal vaccines; pharmacovigilance; postvaccination syncope; student health services.

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References

    1. CDC. Meningococcal Disease. 2016. Available at: http://www.cdc.gov/meningococcal/index.html. Accessed May 11, 2016.
    1. Cohn AC, MacNeil JR, Clark TA, et al. Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2013;62(RR-2):1–28. - PubMed
    1. MacNeil J Considerations for Use of Serogroup B Meningococcal (MenB) Vaccines in Adolescents Advisory Committee on Immunization Practices; June 24, 2015; Atlanta, GA.
    1. McNamara LA, Shumate AM, Johnsen P, et al. First Use of a Serogroup B Meningococcal Vaccine in the US in Response to a University Outbreak. Pediatrics. 2015;135 (5):798–804. - PMC - PubMed
    1. IND safety reporting. 21 CFR § 312.32 (2010).

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