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Demonstrated immune response

Infants, toddlers, children, and adolescents all achieved titers considered protective 1 month after series completion[1]

  • Persistence of bactericidal antibodies in infants has been demonstrated up to 28 months after primary series completion and booster dose[4]

Safety information[1]

The safety of Bexsero was evaluated in 17 studies including 10 randomised controlled clinical trials with 10565 subjects (from 2 months of age) who received at least one dose of Bexsero.[1]

Summary of common and very common adverse reactions:

Bexsero given alone[1]

Frequency of fever with Bexsero is comparable to that associated with routine infant vaccines administered during clinical trials.

Bexsero given with other vaccines[1]

Bexsero may cause fever in infants and children (that generally resolves the day after vaccination), more commonly when co-administered with other vaccines.*

*Pneumococcal 7-valent conjugate vaccine, diphtheria, tetanus, acellular pertussis, hepatitis B recombinant, inactivated poliomyelitis and conjugated Haemophilus influenzae type b vaccine.

Separate vaccinations can be considered when possible.

References:

  1. Bexsero Summary of Product Characteristics. Available from:https://www.medicines.ie/medicines/bexsero-suspension-for-injection-in-pre-filled-syringe-31445/ Last accessed November 2018
  2. Vesikari T, Prymula P, Merrall E, Kohl I, Toneatto D, Dull PM. Meningococcal serogroup B vaccine (4CMenB):booster dose in previously vaccinated infants and primary vaccination in toddlers and two-year-old children. Vaccine. 2015;33:3850-3858.
  3. Santolaya ME, O’Ryan ML, Valenzuela MT, et al. Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study. Lancet. 2012;379:617-624.
  4. Snape MD, Phillip J, John TM, et al. Bactericidal antibody persistence 2 years after immunization with 2 investigational serogroup B meningococcal vaccines at 6, 8 and 12 months and immunogenicity of preschool booster doses: a follow-on study to a randomized clinical trial. Pediatr Infect Dis J. 2013;32:1116–1121.

Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse reactions can also be reported to the HPRA by calling: (01) 6764971. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

Bexsero is a registered trademark of the GlaxoSmithKline Group of Companies