| 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Meningococcal vaccines, ATC code: J07AH08. ATC code added
Figures in bold are updated from previous version of SmPC
Table 1: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 11-18 years
|
Serogroup
|
N
|
GMT
(95% CI)
|
hSBA > 1:8
(95% CI)
|
|
A
|
1075
|
29 (24 , 35)
|
75% (73 , 78)
|
|
C
|
1396
|
50 (39, 65)
|
85% (83, 87)
|
|
W135
|
1024
|
87 (74, 102)
|
96% (95, 97)
|
|
Y
|
1036
|
51 (42, 61)
|
88% (85, 90)
|
Immunogenicity in adults
In the pivotal immunogenicity trial, V59P13, immune responses to Menveo were assessed among adults aged 19 to 55 years. Results are presented in Table 4. In the subset of subjects aged 19-55 years who were seronegative at baseline, the proportion of subjects who achieved a titer ≥ 1:8 after a dose of Menveo were as follows: serogroup A 67% (582/875); serogroup C 71% (401/563); serogroup W135 82% (131/160); serogroup Y 66% (173/263).
Table 4: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 19-55 years
|
Serogroup
|
N
|
GMT
(95% CI)
|
hSBA ≥ 1:8
(95% CI)
|
|
A
|
963
|
31 (27, 36)
|
69% (66, 72)
|
|
C
|
902
|
50 (43, 59)
|
80% (77, 83)
|
|
W135
|
484
|
111 (93, 132)
|
94% (91, 96)
|
|
Y
|
503
|
44 (37, 52)
|
79% (76, 83)
|
Section 6.3
Shelf Life changed from 2 years to 3 years
Section 6.5
Nature and contents of container - added "... or type II elastomeric closure latex free)
Section 10
Date of Revision of Text changed to July 2011
|
