1. Adverse Events Following Vaccination With Bivalent rLP2086 (Trumenba®): An Observational, Longitudinal Study During a College Outbreak and a Systematic Review.
- Author
-
Fiorito TM, Baird GL, Alexander-Scott N, Bornschein S, Kelleher C, Du N, and Dennehy PH
- Subjects
- Adolescent, Adult, Antigens, Bacterial, Bacterial Proteins, Disease Outbreaks statistics & numerical data, Female, Humans, Longitudinal Studies, Male, Mass Vaccination statistics & numerical data, Meningitis, Meningococcal epidemiology, Meningococcal Vaccines administration & dosage, Rhode Island epidemiology, Young Adult, Disease Outbreaks prevention & control, Drug-Related Side Effects and Adverse Reactions epidemiology, Mass Vaccination adverse effects, Meningitis, Meningococcal prevention & control, Meningococcal Vaccines adverse effects
- Abstract
Background: In February 2015, two unlinked culture-confirmed cases of Neisseria meningitidis serogroup B (MenB) disease occurred at a local college in Rhode Island ("college X") within 3 days. This represented a 489-fold increase in the incidence of MenB disease, and an outbreak was declared. For the first time, bivalent rLP2086 (Trumenba) was selected as a mandatory intervention response. A mass vaccination clinic was coordinated, which provided a unique opportunity to collect safety data in a real-world population of college-age participants. Though the Advisory Committee on Immunization Practices recommends MenB vaccination for college-age individuals (16-23 year olds), there is limited quantifiable safety data available for this population., Methods: The Dillman total design survey method was used. Adverse events of bivalent rLP2086 were solicited and quantified retrospectively 2-4 months following each dose of vaccine. Safety data from six clinical trials were used as comparison tools., Results: The most commonly reported adverse event following vaccination was injection site pain. Reported rates of injection site pain, fatigue, myalgia, fever, and chills were similar than those reported in clinical trials. Reported rates of headache were lower than in clinical trials., Conclusions: This study is the first to examine adverse events of bivalent rLP2086 in a real-world setting where more than 90% of a college-age population was vaccinated.
- Published
- 2018
- Full Text
- View/download PDF