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 (2+1 or 3+1). 7
Safety information 3
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. 3
Summary of common and very common adverse reactions:
For a full list of adverse events, please see the current prescribing information which is available here
Bexsero given alone 3
Frequency of fever with Bexsero is comparable to that associated with routine infant vaccines in clinical trials.
Bexsero given with other vaccines 3
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.
- Martinon-Torres F et al. J Infect. 2018;76:258-269;
- Vesikari T et al. Vaccine 2015; 33:3850–3858;
- GSK. 2020. Bexsero SPC. https://www.medicines.ie/medicines/bexsero-suspension-for-injection-in-pre-filled-syringe-31445/smpc (accessed December 2020);
- Santolaya ME et al. Lancet 2012; 379:617–624
- 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.
- 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.
- 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.