BEXSERO OFFERS DEMONSTRATED IMMUNE RESPONSE
BEXSERO demonstrated serum bactericidal activity against 3 component strains prevalent among meningitis B (MenB) strains in the US.1,*
| ≥4-Fold hSBA response rates 1 month post-Dose 21,† |
||
|---|---|---|
| Canada/ Australia Study‡ (11–17 years of age) |
United Kingdom Study§ (18–24 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) |
| Composite hSBA response rates1,# |
||
|---|---|---|
| Canada/ Australia Study‡ (11–17 years of age) |
United Kingdom Study§ (18–24 years of age) |
|
| % (95% CI; N=298-299)†,|| |
% (95% CI; N=147-148)†,¶ |
|
| Baseline | 0 | 24 (18, 30) |
| 1 Month post-Dose 2 | 63 (57,68) | 88 (82, 93) |
| 11 Months post-Dose 2 | — | 66 (58, 72) |
*
Immune response data were recorded for antigens fHbp, NadA, and PorA P1.4.1 However, a suitable strain for assessing immune response was not available for component NHBA.
†
≥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.
‡
The Canada/Australia study was an uncontrolled study. Adolescents 11-17 years of age received 1 or 2 doses of BEXSERO 1 month apart (N=338).1
§
The UK study was a randomized, controlled study. University students 18-24 years of age received either 1 or 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).1
||
LLOQ=1:16 for fHbp, 1:16 for NadA, and 1:8 for PorA P1.4
¶
LLOQ=1:16 for fHbp, 1:8 for NadA, and 1:16 for PorA P1.4.
#
Composite hSBA response is defined as hSBA ≥LLOQ for all 3 indicator MenB strains.
Although vaccine efficacy is inferred from immunogenicity studies, the duration of clinical disease protection after MenB vaccination is not known.2
Vaccination may not protect all recipients.
