Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older

Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.

Abstract

Background: The MenB-FHbp vaccine (Trumenba®) is licensed in various countries for the prevention of meningococcal serogroup B disease in individuals ≥ 10 years of age. The clinical development program included 11 completed trials where, in each trial, MenB-FHbp had an acceptable safety profile after a primary vaccination series was administered to individuals 10-65 years of age. However, the detection of potential rare events was limited because of individual clinical trial size. The current safety analysis evaluates pooled reactogenicity and other adverse events (AEs) reported in these trials to identify new safety signals not detectable in individual trials.

Methods: Eleven trials contributed safety data, of which 10 recorded local and systemic reactogenicity events; 8 of the trials were controlled, and reactogenicity data were pooled for 7 of these 8 trials. Additional AE evaluations included immediate AEs (IAEs), medically attended AEs (MAEs), serious AEs (SAEs), newly diagnosed chronic medical conditions (NDCMCs), and autoimmune or neuroinflammatory conditions.

Results: Local and systemic reactions were more frequent in the MenB-FHbp group (n = 15,294) compared with controls (n = 5509), although most reactions were transient and mild to moderate in severity. Frequencies of IAEs, SAEs, MAEs, NDCMCs, and autoimmune or neuroinflammatory conditions were similar between the MenB-FHbp and control groups.

Conclusions: MenB-FHbp demonstrated a favorable safety and tolerability profile in the clinical development program of > 15,000 vaccine recipients ≥ 10 years of age. No new safety signals were identified in the pooled analysis compared with data from the individual trials. Continued postmarketing safety surveillance is important for the identification of rare events. Clinicaltrials.gov: NCT01299480; NCT000808028; NCT00879814; NCT00780806; NCT01352845; NCT01352793; NCT01461993; NCT01323270; NCT01830855; NCT01461980; NCT01768117.

Trial registration: ClinicalTrials.gov NCT00780806 NCT01830855 NCT01323270 NCT01352793 NCT01768117 NCT01461993 NCT01299480 NCT00879814 NCT01461980 NCT01352845 NCT00808028.

Keywords: Clinical trial; Invasive meningococcal disease; Safety; Serogroup B; Vaccines.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antigens, Bacterial
  • Child
  • Clinical Trials as Topic
  • Humans
  • Immunotherapy
  • Meningococcal Infections* / prevention & control
  • Meningococcal Vaccines* / adverse effects
  • Neisseria meningitidis, Serogroup B*
  • Records

Substances

  • Antigens, Bacterial
  • Meningococcal Vaccines

Associated data

  • ClinicalTrials.gov/NCT00780806
  • ClinicalTrials.gov/NCT01830855
  • ClinicalTrials.gov/NCT01323270
  • ClinicalTrials.gov/NCT01352793
  • ClinicalTrials.gov/NCT01768117
  • ClinicalTrials.gov/NCT01461993
  • ClinicalTrials.gov/NCT01299480
  • ClinicalTrials.gov/NCT00879814
  • ClinicalTrials.gov/NCT01461980
  • ClinicalTrials.gov/NCT01352845
  • ClinicalTrials.gov/NCT00808028