BEXSERO DEMONSTRATED SERUM BACTERICIDAL ACTIVITY BY INDUCING BACTERICIDAL ANTIBODY RESPONSES TO 3 ANTIGENIC COMPONENTS OF BEXSERO, EACH USING A RESPECTIVE STRAIN REPRESENTATIVE OF THOSE PREVALENT IN THE US"scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1,*

≥4-fold hSBA response rates 1 month post-dose"scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1,†
  Canada/Australia Study
(11 through 17 years of age)
United Kingdom Study§
(18 through 24 years of age)
Strain (antigen) % (95% CI; N=298-299)†,∥ % (95% CI; N=147-148)†,¶
H44/76 (fHbp) 98 (95, 99) 78 (71, 85)
5/99 (NadA) 99 (98, 100) 94 (89, 97)
NZ98/254 (PorA P1.4) 39 (33, 44) 67 (58, 74)
A suitable strain for assessing bactericidal activity of NHBA-specific antibodies was not available."scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1
 
Composite hSBA response rates"scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1,#
  Canada/Australia Study
(11 through 17 years of age)
United Kingdom Study§
(18 through 24 years of age)
  % (95% CI; N=298-299) % (95% CI; N=136-186)
Baseline 0 24 (18, 30)
1 month post-dose 2 63 (57, 68) 88 (82, 93)
11 months post-dose 2 -- 66 (58, 72)
  CI=Confidence interval; hSBA=human serum bactericidal assay; LLOQ=lower limit of quantification.
* Immune response data were recorded for antigens fHbp, NadA, and PorA P1.4. However, a suitable strain for assessing immune response was not available for component NHBA."scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1
≥4-fold hSBA response is defined as a postvaccination hSBA ≥1:16 for participants with prevaccination hSBA <1:4; a postvaccination titer at least 4-fold the LLOQ for participants with prevaccination hSBA ≥1:4 but <LLOQ, and a postvaccination 4-fold rise for participants with prevaccination hSBA ≥LLOQ."scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1
The Canada/Australia study was an uncontrolled study. Adolescents 11 through 17 years of age received 2 doses of BEXSERO 1 month apart (N=338)."scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1
§ The United Kingdom study was a randomized, controlled study. University students 18 through 24 years of age received either 2 doses of BEXSERO 1 month apart (N=932) or 1 dose of MENVEO® (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) followed by 1 dose of placebo containing aluminum hydroxide (N=956) or 2 doses of IXIARO® (Japanese Encephalitis Vaccine, Inactivated, Absorbed) (N=947)."scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1
LLOQ=1:16 for fHbp; 1:16 for NadA; 1:8 for PorA P1.4.1
LLOQ=1:16 for fHbp; 1:8 for NadA; 1:16 for PorA P1.4.1
# Composite hSBA response is defined as hSBA ≥LLOQ for all 3 indicator MenB strains.1

 

INDICATION

BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals 10 through 25 years of age.

Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of BEXSERO against diverse serogroup B strains has not been confirmed.

IMPORTANT SAFETY INFORMATION FOR BEXSERO

  • BEXSERO is contraindicated in cases of hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of BEXSERO
  • Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine
  • The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals
  • Syncope (fainting) can occur in association with administration of BEXSERO. Ensure procedures are in place to avoid injury from falling associated with syncope
  • The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥28%), nausea (≥18%), and arthralgia (≥13%)
  • Vaccination with BEXSERO may not provide protection against all meningococcal serogroup B strains
  • Vaccination with BEXSERO may not result in protection in all vaccine recipients

Please see full Prescribing Information for BEXSERO.