Safety of a Meningococcal Group B Vaccine Used in Response to Two University Outbreaks

Autor/inn/en	Duffy, Jonathan; Johnsen, Peter; Ferris, Mary; Miller, Mary; Leighton, Kevin; McGilvray, Mark; McNamara, Lucy; Breakwell, Lucy; Yu, Yon; Bhavsar, Tina; Briere, Elizabeth; Patel, Manisha
Titel	Safety of a Meningococcal Group B Vaccine Used in Response to Two University Outbreaks
Quelle	In: Journal of American College Health, 65 (2017) 6, S.380-388 (9 Seiten) PDF als Volltext Verfügbarkeit
Sprache	englisch
Dokumenttyp	gedruckt; online; Zeitschriftenaufsatz
ISSN	0744-8481
DOI	10.1080/07448481.2017.1312418
Schlagwörter	Diseases; Immunization Programs; Hospitals; Safety; Undergraduate Students; Dormitories; Clinics; Observation; Surveys; Incidence; Pain; Injuries; Prevention; Health Services; Questionnaires; Student Attitudes; Allergy; New Jersey; California + Suchen Sie Ihr Suchwort? Disease; Krankheit; Immunisierung; Krankengymnast; Krankenhaus; Sicherheit; Student housing; Studentenwohnheim; Beobachtung; Survey; Umfrage; Befragung; Vorkommen; Schmerz; Prävention; Vorbeugung; Health service; Gesundheitsdienst; Gesundheitswesen; Fragebogen; Schülerverhalten; Allergie; Kalifornien
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. (As Provided).
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Erfasst von	ERIC (Education Resources Information Center), Washington, DC
Update	2020/1/01