Short-term safety of 4CMenB vaccine during a mass meningococcal B vaccination campaign in Quebec, Canada

Vaccine. 2018 Dec 18;36(52):8039-8046. doi: 10.1016/j.vaccine.2018.10.095. Epub 2018 Nov 19.


Background: To address a high incidence of serogroup B invasive meningococcal disease (IMD-B) in the Saguenay-Lac-Saint-Jean region, Quebec, Canada, a mass vaccination campaign targeting nearly 60,000 individuals ≤20 years old was launched in May 2014. Because of the limited clinical experience with the four-component meningococcal B vaccine (4CMenB), active surveillance for adverse events following immunization (AEFI) was conducted. This paper reports 4CMenB AEFI surveillance findings.

Methods: Active surveillance assessed AEFIs with acute onset within 7-days post-immunization, AEFI-associated absenteeism and medical consultations, impact of antipyretic prophylaxis and coadministration of other vaccines.

Results: By July 17, 2015, 83% and 77% of the 59,098 individuals targeted by the campaign had received a first and a second dose of 4CMenB. The incidence of fever on days1-2 was highest in children <2 years old but only 0.6% reported a temperature ≥40C. Among children <10 years old, ≥2doses of acetaminophen prophylaxis significantly reduced fever incidence on days1-2 after dose1&2. Absenteeism or a medical consultation during the 7 days following vaccination was reported by 6.2% of vaccinees post-dose1 and 9.2% post-dose2 and was most often reported in association with fever/malaise (4.2%) or injection site reactions (3.6%).

Conclusion: Large-scale population-based surveillance identified a 7-day reactogenicity profile consistent with earlier clinical trials with the 4CMenB vaccine but indicating frequent AEFI-associated absenteeism and medical consultations affecting the societal cost of this vaccine. We conclude acceptable vaccine safety and risk-benefit profile overall on the short term, particularly as an intervention to address a high regional incidence of IMD-B.

Keywords: 4CMenB; Meningococcal vaccine; Reactogenicity; Vaccine safety.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetaminophen / therapeutic use
  • Adolescent
  • Child
  • Child, Preschool
  • Female
  • Fever / drug therapy
  • Fever / etiology
  • Humans
  • Immunization Programs*
  • Immunization Schedule
  • Incidence
  • Male
  • Meningococcal Infections / prevention & control*
  • Meningococcal Vaccines / administration & dosage*
  • Meningococcal Vaccines / adverse effects
  • Neisseria meningitidis, Serogroup B / immunology
  • Quebec
  • Vaccination Coverage / statistics & numerical data
  • Young Adult


  • 4CMenB vaccine
  • Meningococcal Vaccines
  • Acetaminophen