Table 2.
Antibody | Population | Placebo group |
Vaccine group |
p values# |
|||||||
---|---|---|---|---|---|---|---|---|---|---|---|
N | Seroconverted n (%) |
GMT (95%CI) | N | Seroconverted n (%) |
GMT (95%CI) | SCR* | GMTs | ||||
Month 7 | |||||||||||
HPV16 | All participants | 532 | 21 (4.0) | 20.7 | (20.4, 21.1) | 504 | 503 (99.8) | 5827 | (5249, 6468) | < .001 | < .001 |
9–17 years | 275 | 4 (1.5) | 20.2 | (20.0, 20.4) | 265 | 264 (99.6) | 8571 | (7437, 9879) | < .001 | < .001 | |
18–26 years | 95 | 4 (4.2) | 20.6 | (20.0, 21.2) | 92 | 92 (100) | 7296 | (5939, 8962) | < .001 | < .001 | |
27–45 years | 162 | 13 (8.0) | 21.7 | (20.6, 22.8) | 147 | 147 (100) | 2524 | (2183, 2918) | < .001 | < .001 | |
HPV18 | All participants | 526 | 9 (1.7) | 20.3 | (20.1, 20.5) | 504 | 503 (99.8) | 4223 | (3785, 4713) | < .001 | < .001 |
9–17 years | 271 | 3 (1.1) | 20.2 | (20.0, 20.3) | 263 | 262 (99.6) | 5826 | (5087, 6672) | < .001 | < .001 | |
18–26 years | 95 | 1 (1.1) | 20.2 | (19.9, 20.4) | 91 | 91 (100) | 3892 | (3103, 4882) | < .001 | < .001 | |
27–45 years | 160 | 5 (3.1) | 20.6 | (20.1, 21.2) | 150 | 150 (100) | 2525 | (2016, 3162) | < .001 | < .001 | |
Month 12 | |||||||||||
HPV16 | All participants | 532 | 10 (1.9) | 20.5 | (20.1, 21.0) | 504 | 503 (99.8) | 1128 | (1030, 1236) | < .001 | < .001 |
9–17 years | 275 | 2 (0.7) | 20.5 | (19.7, 21.4) | 265 | 265 (100) | 1578 | (1408, 1768) | < .001 | < .001 | |
18–26 years | 95 | 1 (1.1) | 20.2 | (19.9, 20.4) | 92 | 92 (100) | 954 | (798, 1140) | < .001 | < .001 | |
27–45 years | 162 | 7 (4.3) | 20.8 | (20.2, 21.4) | 147 | 146 (99.3) | 684 | (572, 817) | < .001 | < .001 | |
HPV18 | All participants | 526 | 6 (1.1) | 20.5 | (19.9, 21.1) | 504 | 489 (97.0) | 1835 | (1581, 2130) | < .001 | < .001 |
9–17 years | 271 | 3 (1.1) | 20.8 | (19.7, 22.0) | 263 | 262 (99.6) | 3111 | (2687, 3603) | < .001 | < .001 | |
18–26 years | 95 | 0 (0.0) | 20.0 | (20.0, 20.0) | 91 | 90 (98.9) | 1360 | (963, 1922) | < .001 | < .001 | |
27–45 years | 160 | 3 (1.9) | 20.3 | (20.0, 20.6) | 150 | 137 (91.3) | 872 | (620, 1226) | < .001 | < .001 |
*SCR: seroconversion rate (% of group who seroconverted); #p values for differences between respective placebo and vaccine groups.
a. iPPS = Immunogenicity Per Protocol Set.