title: Safety of a meningococcal group B vaccine used in response to two university outbreaks.
abstract: To assess the safety of meningococcal group B (MenB)-4C vaccine.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  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.
authors.affiliation: a Immunization Safety Office, Centers for Disease Control and Prevention , Atlanta , Georgia, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Duffy
authors.affiliation: b University Health Services, Princeton University , Princeton , New Jersey , USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Johnsen
authors.affiliation: c Student Health Service , University of California Santa Barbara , Santa Barbara , California , USA.
authors.forename: Mary
authors.initials: M
authors.lastname: Ferris
authors.affiliation: c Student Health Service , University of California Santa Barbara , Santa Barbara , California , USA.
authors.forename: Mary
authors.initials: M
authors.lastname: Miller
authors.affiliation: b University Health Services, Princeton University , Princeton , New Jersey , USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Leighton
authors.affiliation: c Student Health Service , University of California Santa Barbara , Santa Barbara , California , USA.
authors.forename: Mark
authors.initials: M
authors.lastname: McGilvray
authors.affiliation: d Meningitis and Vaccine-Preventable Diseases Branch , Centers for Disease Control and Prevention , Atlanta , Georgia , USA.
authors.forename: Lucy
authors.initials: L
authors.lastname: McNamara
authors.affiliation: d Meningitis and Vaccine-Preventable Diseases Branch , Centers for Disease Control and Prevention , Atlanta , Georgia , USA.
authors.forename: Lucy
authors.initials: L
authors.lastname: Breakwell
authors.affiliation: e Regulatory Affairs, Office of the Director , National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia , USA.
authors.forename: Yon
authors.initials: Y
authors.lastname: Yu
authors.affiliation: e Regulatory Affairs, Office of the Director , National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia , USA.
authors.forename: Tina
authors.initials: T
authors.lastname: Bhavsar
authors.affiliation: d Meningitis and Vaccine-Preventable Diseases Branch , Centers for Disease Control and Prevention , Atlanta , Georgia , USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Briere
authors.affiliation: d Meningitis and Vaccine-Preventable Diseases Branch , Centers for Disease Control and Prevention , Atlanta , Georgia , USA.
authors.forename: Manisha
authors.initials: M
authors.lastname: Patel
mesh_terms: D000328:Adult; D004196:Disease Outbreaks / Q000517:prevention & control*; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008589:Meningococcal Infections / Q000453:epidemiology / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage*; D038541:Neisseria meningitidis, Serogroup B; D013334:Students / Q000706:statistics & numerical data; D011795:Surveys and Questionnaires; D014495:Universities
chemical_list: D022401:Meningococcal Vaccines
keywords: Latex hypersensitivity; Neisseria meningitidis serogroup B; meningococcal vaccines; pharmacovigilance; postvaccination syncope; student health services