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

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BEXSERO demonstrated a positive response in subjects aged 11 through 17 and 18 through 24 years of age.

Bactericidal Antibody Response Rates

  Canada/Australia Study*
(11 through 17 years of age)
United Kingdom Study
(18 through 24 years of age)
≥4-FOLD hSBA RESPONSE 1 MONTH POSTDOSE 2a‡
Strain (antigen) % (95% CI)
N=298-299b
% (95% CI)
N=147-148c
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)
COMPOSITE hSBA RESPONSEd
Time point % (95% CI)
N=298-299b
% (95% CI)
N=136-186c
Baseline
(prevaccination)
0 24 (18, 30)
1 month
postdose 2
63 (57, 68) 88 (82, 93)
11 months
postdose 2
  66 (58, 72)

CI=confidence interval; hSBA=serum bactericidal activity measured using human complement;
LLOQ=lower limit of quantitation.

fHbp=factor H binding protein; NadA=Neisserial adhesin A; NHBA=Neisserial Heparin Binding Antigen; PorA P1.4 present in Outer Membrane Vesicles (OMV).

a ≥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.
b LLOQ=1:16 for fHbp; 1:16 for NadA; 1:8 for PorA P1.4.
c LLOQ=1:16 for fHbp; 1:8 for NadA; 1:16 for PorA P1.4.
d Composite hSBA response means hSBA ≥LLOQ for all 3 indicator meningococcal B strains.
* 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).
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 (comparator group) 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, Adsorbed) (n=947).
Vaccination with BEXSERO leads to the production of antibodies directed against fHbp, NadA, NHBA, and PorA P1.4 (present in OMV). A suitable strain for assessing bactericidal activity of NHBA-specific antibodies was not available.

References

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709301R0 May 2016