Serogroup |
Men+Tdap+HPV |
Placebo+Tdap+HPV |
|
n |
GMT / % of subjects |
n |
GMT / % of subjects |
A |
371 |
|
99 |
|
GMTs |
|
|
|
|
Baseline |
|
2.2 (2.1, 2.3) |
|
2.1 (2.0, 2.3) |
1 month post-vaccination |
|
35 (29, 42) |
|
2.1(2.0, 2.3) |
hSBAtiter ≥8, % |
|
77 (72, 81) |
|
2 (0, 7) |
Seroresponders, % |
|
75 (70, 80) |
|
1 (0, 5) |
C |
370 |
|
97 |
|
GMTs |
|
|
|
|
Baseline |
|
4.4 (4.0, 4.9) |
|
3.9 (3.3, 4.6) |
1 month post-vaccination |
|
59 (48, 73) |
|
3.9 (3.3, 4.7) |
hSBA titer ≥8, % |
|
84 (80, 88) |
|
21 (13, 30) |
Seroresponders, % |
|
69 (64, 74) |
|
2 (0, 7) |
W-135 |
369 |
|
96 |
|
GMTs |
|
|
|
|
Baseline |
|
12 (10, 14) |
|
12 (9.1, 16) |
1 month post-vaccination |
|
61 (53, 69) |
|
12 (9.3, 17) |
hSBAtiter ≥8, % |
|
95 (93, 97) |
|
67 (56, 76) |
Seroresponders, % |
|
49 (44, 54) |
|
5 (2, 12) |
Y |
369 |
|
97 |
|
GMT |
|
|
|
|
Baseline |
|
4.1 (3.7, 4.6) |
|
3.5 (2.8, 4.3) |
1 month post-vaccination |
|
48 (40, 58) |
|
3.5 (2.9, 4.3) |
hSBAtiter ≥8, % |
|
86 (82, 89) |
|
22 (14, 31) |
Seroresponders, % |
|
69 (64, 74) |
|
3 (1, 9) |
|
Table 3: Immunogenicity endpoints for meningococcal serogroups A,
C, W-135 and Y responses. hSBA GMTs, percentage of subjects with
hSBA titer ≥8, and percentage of seroresponders against serogroups A,
C, W-135, and Y, at baseline (GMTs only) and one month post
vaccination, by group. |