BEXSERO

Help protect infants and toddlers from invasive disease caused by N. meningitidis serogroup B strains (MenB). 1

• In a large phase 3 clinical trial (V72P13), the majority of infants 2 to 12 months of age had demonstrated immune response after priming with BEXSERO.*†
  
• Immune response was shown up to 1 year after BEXSERO vaccination.*†

Immune response shown with BEXSERO primary series given at 2, 4, and 6 months of age, and a booster dose given at 12 months of age (V72P13 trial) 1,3*†

• The immunogenicity after two doses (at 3½ and 5 months of age) or three doses (at 2½, 3½ and 5 months of age) of BEXSERO followed by a booster has been evaluated in an additional phase 3 clinical study (Study V72_28). The percentages of seropositive subjects (i.e. achieving an hSBA of at least 1:4) ranged from 44% to 100% one month after the second dose and from 55% to 100% one month after the third dose, respectively for the two-dose schedule and the three-dose schedule. 1
  
• At one month following a booster administered 6 months after the last primary dose, the percentages of seropositive subjects ranged from 87% to 100% for the two-dose schedule, and from 83% to 100% for the three-dose schedule. 1
  
• Antibody persistence was evaluated in an extension study in children 3 to 4 years of age (Study V72_28E1). At 2 to 3 years after the completion of the vaccination course in Study V72_28, the antibody levels declined against all strains in both 2+1 and 3+1 schedules; the percentages of seropositive subjects (i.e. achieving an hSBA of at least 1:4) ranged from 35% to 91% or from 36% to 84%, respectively. 1
  
• In a phase 2 (V72P9) study of infants 6 to 11 months of age, and a phase 3 (V72P13E1) study of toddlers 12 to 23 months of age, BEXSERO demonstrated serum bactericidal antibody responses after two doses.*‡§

Demonstrated immune response 1 month following second dose of BEXSERO given at 6 and 8 months of age from the V72P9 study 1*‡

Demonstrated immune response with BEXSERO vaccination at 13 and 15 months of age (V72P13E1) 1*§

BEXSERO is not expected to provide protection against all circulating meningococcal serogroup B strains and does not offer protection against other meningococcal strains (e.g., A, C, Y, W-135). As with any vaccine, BEXSERO may not protect all vaccine recipients.

In infants and children ≤2 years of age, the most frequent local and systemic adverse reactions after vaccination with BEXSERO were: tenderness, erythema, induration, fever, irritability, unusual crying, and sleepiness.

* Clinical significance unknown.

† Study V72P13: A partially blinded, multicentre, randomized, controlled study that evaluated the safety and immunogenicity of BEXSERO in infants 2 to 12 months of age (N=3630)

‡ Study V72P9: Single-blind, single-centre, randomized study that evaluated the safety in immunogenicity of BEXSERO in infants 6 to 8 months of age (N=60)

§ Study V72P13E1: Open-label, multicentre, randomized study that evaluated the safety in immunogenicity of BEXSERO in children starting at 12 months of age (N=2249)

fHbp=factor H binding protein; hSBA=human serum bactericidal activity; NadA=Neisserial adhesin A; NHBA=Neisseria heparin-binding antigen; PorA=Porin A

Help protect children and adolescents from invasive disease caused by N. meningitidis serogroup B strains (MenB). 1,4

• In a phase 3 (V72P13E2) study of children 2 to 10 years of age, and a phase 2b (V72P10) study of adolescents 11 to 17 years of age, the majority of subjects had demonstrated immune response after receiving BEXSERO.*†‡

Demonstrated immune response 1 month following second dose of BEXSERO given at 24 and 26 months of age 1*†

Demonstrated immune response 1 month following second dose of BEXSERO given between 11 and 17 years of age 1*‡

BEXSERO is indicated for active immunization of individuals from 2 months through 25 years old against invasive disease caused by Neisseria meningitidis serogroup B strains. BEXSERO is not indicated for use in individuals >25 years of age.

BEXSERO is not expected to provide protection against all circulating meningococcal serogroup B strains and does not offer protection against other meningococcal strains (e.g., A, C, Y, W-135). As with any vaccine, BEXSERO may not protect all vaccine recipients.

In adolescents and adults (11 years or older), the most frequent local and systemic adverse reactions after vaccination with BEXSERO were: pain, erythema, induration, malaise, headache, and myalgia.

* Clinical significance unknown.

† Study V72P13E2: An open-label, randomized, multicentre, extension study in children 24 to 27 months of age (N=508)

‡ Study V72P10: An observer blind, multicentre, randomized, placebo-controlled study in adolescents 11 to 17 years of age (N=1631)

§ Study V72_75: An open-label, multicentre, extension study in adolescents and adults 15 to 24 years of age (N=531)

fHbp=factor H binding protein; hSBA=human serum bactericidal activity; NadA=Neisserial adhesin A; NHBA=Neisseria heparin-binding antigen; PorA=Porin A