Background: MenB-FHbp (bivalent rLP2086) was the first vaccine licensed in the US through an accelerated approval process to prevent invasive meningococcal serogroup B (MnB) disease in individuals aged 1025 years. Confirmatory immunogenicity and safety studies have been completed, with a large proportion of subjects having been enrolled in the United States. We present data from the safety evaluations of US subjects enrolled in one of 3 large phase 3 studies.
Methods: Healthy subjects aged 18 to <26 years were randomized to MenB-FHbp or saline at 0, 2, and 6 months. Safety variables, including local, systemic reactions and antipyretic use within 7 days after vaccination, and unsolicited adverse events (AEs), including immediate AEs, medically-attended AEs (MAEs), SAEs, and newly diagnosed chronic medical conditions (NDCMCs), were assessed.
Results: 2471 and 822 subjects received MenB-FHbp or saline, respectively; 1644 were from the US (MenB-FHbp, n=1232; saline, n=412). Local and systemic reactions were more common with MenB-FHbp, mostly mild or moderate in severity, and more frequent after the first vaccination. Injection-site pain (83.7%) and fatigue (59.0%) were the most common local and systemic reactions with MenB-FHbp, respectively (Figure). 4.1% and 1.0% of MenB-FHbp and control recipients reported fever ≥38°C (Figure) and 17.6% and 7.8%, respectively, used antipyretics. One MenB-FHbp recipient reported fever >40.0°C which lasted 1 day. Worsening of severity of local and systemic events with subsequent vaccinations was not observed. Few SAEs were reported overall among US subjects. Similar rates of AEs, SAEs MAEs, and NDCMC were reported between groups; Table).
Conclusion: MenB-FHbp was safe and tolerable among US adolescents. Results were consistent with the safety profile observed in the global study.
J. F. Beeslaar, Pfizer Ltd: Employee and Shareholder , Salary and Stock, Stock options, and long term projections
J. J. Eiden, Pfizer, Inc: Employee , Salary
K. U. Jansen, Pfizer, Inc: Employee and Shareholder , Salary
J. Absalon, Pfizer, Inc: Employee , Salary
L. J. York, Pfizer, Inc: Employee , Salary
D. Radley, Pfizer, Inc: Employee and Shareholder , Salary
J. L. Prégaldien, Pfizer Ltd: Employee , Salary
N. Breinholt Staerke, Pfizer, Inc: Investigator , Study Sponsored by Pfizer
J. L. Perez, Pfizer, Inc: Employee , Salary