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Safety of a meningococcal group B vaccine used in response to two university outbreaks.
J Am Coll Health 2017 Aug-Sep; 65(6):380-388JA

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.

Authors+Show Affiliations

a Immunization Safety Office, Centers for Disease Control and Prevention , Atlanta , Georgia, USA.b University Health Services, Princeton University , Princeton , New Jersey , USA.c Student Health Service , University of California Santa Barbara , Santa Barbara , California , USA.c Student Health Service , University of California Santa Barbara , Santa Barbara , California , USA.b University Health Services, Princeton University , Princeton , New Jersey , USA.c Student Health Service , University of California Santa Barbara , Santa Barbara , California , USA.d Meningitis and Vaccine-Preventable Diseases Branch , Centers for Disease Control and Prevention , Atlanta , Georgia , USA.d Meningitis and Vaccine-Preventable Diseases Branch , Centers for Disease Control and Prevention , Atlanta , Georgia , USA.e Regulatory Affairs, Office of the Director , National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia , USA.e Regulatory Affairs, Office of the Director , National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia , USA.d Meningitis and Vaccine-Preventable Diseases Branch , Centers for Disease Control and Prevention , Atlanta , Georgia , USA.d Meningitis and Vaccine-Preventable Diseases Branch , Centers for Disease Control and Prevention , Atlanta , Georgia , USA.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

28362241

Citation

Duffy, Jonathan, et al. "Safety of a Meningococcal Group B Vaccine Used in Response to Two University Outbreaks." Journal of American College Health : J of ACH, vol. 65, no. 6, 2017, pp. 380-388.
Duffy J, Johnsen P, Ferris M, et al. Safety of a meningococcal group B vaccine used in response to two university outbreaks. J Am Coll Health. 2017;65(6):380-388.
Duffy, J., Johnsen, P., Ferris, M., Miller, M., Leighton, K., McGilvray, M., ... Patel, M. (2017). Safety of a meningococcal group B vaccine used in response to two university outbreaks. Journal of American College Health : J of ACH, 65(6), pp. 380-388. doi:10.1080/07448481.2017.1312418.
Duffy J, et al. Safety of a Meningococcal Group B Vaccine Used in Response to Two University Outbreaks. J Am Coll Health. 2017;65(6):380-388. PubMed PMID: 28362241.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety of a meningococcal group B vaccine used in response to two university outbreaks. AU - Duffy,Jonathan, AU - Johnsen,Peter, AU - Ferris,Mary, AU - Miller,Mary, AU - Leighton,Kevin, AU - McGilvray,Mark, AU - McNamara,Lucy, AU - Breakwell,Lucy, AU - Yu,Yon, AU - Bhavsar,Tina, AU - Briere,Elizabeth, AU - Patel,Manisha, Y1 - 2017/05/08/ PY - 2017/4/1/pubmed PY - 2019/4/4/medline PY - 2017/4/1/entrez KW - Latex hypersensitivity KW - Neisseria meningitidis serogroup B KW - meningococcal vaccines KW - pharmacovigilance KW - postvaccination syncope KW - student health services SP - 380 EP - 388 JF - Journal of American college health : J of ACH JO - J Am Coll Health VL - 65 IS - 6 N2 - 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. SN - 1940-3208 UR - https://www.unboundmedicine.com/medline/citation/28362241/Safety_of_a_meningococcal_group_B_vaccine_used_in_response_to_two_university_outbreaks L2 - http://www.tandfonline.com/doi/full/10.1080/07448481.2017.1312418 DB - PRIME DP - Unbound Medicine ER -