Safety of MenB-FHbp (Bivalent rLP2086), a Meningococcal Serogroup B Vaccine, in Young Adults: Results From a Phase 3 Trial
Bibliographic record
Abstract
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 10–25 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. A total of 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. Disclosures. 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
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".