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Immunogenicity Data

BEXSERO: Demonstrated immune response

Bexsero has demonstrated a protective immune response in infants, toddlers, children, adolescents, and adults. 1

87% - 100% of infants, toddlers, children§, and adolescent achieved titers considered protective 1 month after series completion with the 2-dose schedule. 1

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Strain specific seroresponses1

*Infants (2–11 months of age) and toddlers (12–23 months of age): Percentage of subjects who achieved an hSBA ≥1:5. children (2–10 years of age): Percentage of subjects who achieved an hSBA ≥1:4 against fHbp, NadA, PorA P1.4 antigens, and an hSBA ≥1:4. 1
For the 2+1 dosing schedule, infants received BEXSERO AT 3 ½ and 5 months, with a booster at 11 months. 
1,7
Vaccinations at 13, 15, and 27 months and of age; N=63–67.
2
§Data show in graph are for children 2-10 years of age following a 0,2-month schedule. Serum bactericidal antibody responses at 1 month following the second dose of BEXSERO given to children 2-10 years of age.
1
Two doses 1 month apart; N=638–639; N=46 for NHBA.
1
The Results showed that 2 years after the last dose the persistence of bacterial antibodies remained above the putative threshold of protection (hSBA ≥1:4) in more than 50% of participants for 5 out of 8 strains tested. 4

BEXSERO: Demonstrated immune response

Bexsero has demonstrated a protective immune response in infants, toddlers, children, adolescents, and adults. 8

95% - 100% of infants, toddlers, children§, and adolescents achieved titers considered protective 1 month after series completion.2,3,8

Strain specific seroresponses2

*Infants (2–11 months of age), toddlers (12–23 months of age), and children (2–10 years of age): Percentage of subjects who achieved an hSBA ≥1:5. Adolescents (11–17 years of age): Percentage of subjects who achieved an hSBA ≥1:4.2,3,8
Vaccinations at 2, 4, and 6 months of age, and booster at 12 months of age; N=421; N=100 for NHBA.
8
Vaccinations at 13, 15, and 27 months and of age; N=63–67. 2
§Vaccinations at 24 and 26 months of age; N=100–108.
8
Two doses 1 month apart; N=638–639; N=46 for NHBA.
8
The Results showed that 2 years after the last dose the persistence of bacterial antibodies to remain above the putative threshold of protection (hSBA ≥1:4) in more than 50% of participants for 5 out of 8 strains tested.
4

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

Strain Coverage

Estimating Strain Coverage with MATS

Meningococcal Antigen Typing System (MATS) analysis of 1000 different invasive MenB isolates collected in 5 EU countries between 2007 and 2008 predicted that 73-87% (95% CI: 63- 90%) would potentially be covered by Bexsero. 1,5

88% of disease-causing strains* have been shown to be killed, in hSBA, by serum from individuals vaccinated with BEXSERO (95% CI: 72–95%). 5

For MenB, only hSBA is reliable as a predictor of protection against disease. 6

*Using a representative panel of 40 MenB isolates (from England and Wales in 2007–2008). 5
Pooled serum derived from 69 infants. 5

References:

  1. BEXSERO Summary of Product Characteristics.
  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.
  5. Frosi G, Biolchi A, Sapio ML, et al. Bactericidal antibody against a representative epidemiological meningococcal serogroup B panel confirms that MATS underestimates 4CMenB vaccine strain coverage. Vaccine. 2013;31:4968-4974.
  6. Granoff DM, Pelton S, Harrison H. Meningococcal vaccines. In: Plotkin SA, Orenstein WA, Offit PA, eds. Vaccines. 6th ed. Philadelphia, PA: Saunders; 2013:388-418.
  7. Martinon-Torres F, Safadi MAP, Martinez AC, et al. Reduced schedules of 4CmenB vaccine in infants and catch-up series in children: immunogenicity and safety results from a randomized open-label phase 3b trial. Vaccine 2017; 35(28):3548-3557.
  8. BEXSERO Product Monograph. GSK Vaccines S.r.l: 2017.

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