Adverse Events Following Vaccination With Bivalent rLP2086 (Trumenba®): An Observational, Longitudinal Study During a...

Area of Science:

• Vaccinology
• Epidemiology
• Public Health

Background:

• An outbreak of Neisseria meningitidis serogroup B (MenB) disease occurred at a college, prompting a mandatory vaccination response.
• Bivalent rLP2086 (Trumenba) was used for the first time in a mass vaccination campaign.
• Limited safety data exists for MenB vaccination in college-age individuals.

Purpose of the Study:

• To evaluate the safety and quantify adverse events of bivalent rLP2086 in a real-world college population.
• To compare real-world safety data with existing clinical trial data.

Main Methods:

• The Dillman total design survey method was employed for data collection.
• Adverse events were solicited retrospectively 2-4 months post-vaccination.
• Safety data from six clinical trials served as a comparison.

Main Results:

• Injection site pain was the most frequent adverse event.
• Reported rates of injection site pain, fatigue, myalgia, fever, and chills were similar to clinical trial findings.
• Headache rates were lower than those observed in clinical trials.

Conclusions:

• This study provides the first real-world safety data for bivalent rLP2086 in a highly vaccinated college-age population.
• The vaccine demonstrated a safety profile consistent with clinical trial results.
• The findings support the recommendation for MenB vaccination in college students.