Table 2.
HPV-16/18 vaccine | HPV-6/11/16/18 vaccine | ||||||||
---|---|---|---|---|---|---|---|---|---|
Antigen | Month | N | n | % P [95% CI] | GMT* [95% CI] | N | n | % P [95% CI] | GMT* [95% CI] |
HPV-16 | 0 | 57 | 2 | 3.5 [0.4, 12.1] | 15.6 [0.8, 321.3] | 64 | 0 | 0 [0.0,0.0] | – [–, –] |
7 | 65 | 62 | 95.4 [87.1, 99.0] | 200.4 [141.6, 283.6] | 82 | 74 | 90.2 [81.7, 95.7] | 92.9 [68.1, 126.5] | |
12 | 67 | 57 | 85.1 [74.3, 92.6] | 121.1 [88.6, 165.5] | 66 | 52 | 78.8 [67.0, 87.9] | 59.0 [43.5, 79.9] | |
18 | 51 | 42 | 82.4 [69.1, 91.6] | 102.1 [70.6, 147.8] | 65 | 41 | 63.1 [50.2, 74.7] | 68.8 [47.7, 99.1] | |
24 | 54 | 42 | 77.8 [64.4, 88.0] | 86.9 [60.7, 124.6] | 61 | 34 | 55.7 [42.4, 68.5] | 43.4 [27.8, 67.5] | |
36 | 60 | 43 | 71.7 [58.6, 82.5] | 57.7 [41.5, 80.4] | 62 | 42 | 67.7 [54.7, 79.1] | 51.5 [36.2, 73.2] | |
48 | 43 | 31 | 72.1 [56.3, 84.7] | 41.6 [29.3, 59.1] | 46 | 25 | 54.3 [39.0, 69.1] | 72.8 [38.5, 137.8] | |
HPV-18 | 0 | 57 | 3 | 5.3 [1.1, 14.6] | 18.9 [8.8, 40.6] | 64 | 4 | 6.3 [1.7, 15.2] | 11.4 [1.4, 96.4] |
7 | 65 | 60 | 92.3 [83.0, 97.5] | 96.7 [73.1, 128.0] | 82 | 57 | 69.5 [58.4, 79.2] | 38.1 [28.0, 51.8] | |
12 | 67 | 54 | 80.6 [69.1, 89.2] | 57.6 [43.2, 76.7] | 67 | 35 | 52.2 [39.7, 64.6] | 36.4 [24.9, 53.1] | |
18 | 51 | 37 | 72.5 [58.3, 84.1] | 40.2 [25.7, 62.9] | 65 | 22 | 33.8 [22.6, 46.6] | 28.7 [16.5, 49.8] | |
24 | 54 | 38 | 70.4 [56.4, 82.0] | 49.0 [33.3, 72.0] | 61 | 22 | 36.1 [24.2, 49.4] | 20.8 [11.7, 36.8] | |
36 | 60 | 41 | 68.3 [55.0, 79.7] | 27.5 [20.3, 37.2] | 62 | 23 | 37.1 [25.2, 50.3] | 30.6 [17.8, 52.7] | |
48 | 43 | 24 | 55.8 [39.9, 70.9] | 24.1 [16.0, 36.2] | 46 | 18 | 39.1 [25.1, 54.6] | 26.1 [13.4, 50.9] |
CI, confidence interval; GMT, geometric mean titer; N, number of subjects with available results; n, number of subjects with an antibody titer ≥ the limit of quantification; P, positivity (defined as antibody titer ≥0.58 ELISA units/mL for HPV-16 and ≥0.35 ELISA units/mL for HPV-18); TVC, total vaccinated cohort.
Month 7–Month 48 data are presented for the TVC corresponding to the time point under analysis.
*GMTs were calculated on positive subjects (n values) because data for all subjects in the subset did not follow a normal distribution. Dashes (–) indicate where there were insufficient values (i.e., n≤ 1) to calculate GMTs.