Table 2. HPV-16 and HPV-18 GMT ratios for 3D schedule in women aged 15–25 y over 2D schedule in girls aged 9–14 y at months 36 and 48 (according-to-protocol month 36 and 48 immunogenicity cohorts, subjects seronegative at baseline).
Antigen | Group | Age (y) | N | GMT (95% CI), EU/mL | GMT ratio (3D/2D) (95% CI) |
---|---|---|---|---|---|
Month 36 | |||||
HPV-16 | 3D 20/20 M0,1,6 | 15–25 | 85 | 1592.0 (1282.6, 1975.9) | 1.00 (0.73, 1.37) |
2D 20/20 M0,6 | 9–14 | 53 | 1595.1 (1298.2, 1960.0) | - | |
HPV-18 | 3D 20/20 M0,1,6 | 15–25 | 81 | 712.3 (560.3, 905.6) | 1.03 (0.72, 1.49) |
2D 20/20 M0,6 | 9–14 | 52 | 689.3 (530.4, 895.9) | - | |
Month 48 | |||||
HPV-16 | 3D 20/20 M0,1,6 | 15–25 | 80 | 1419.6 (1133.9, 1777.2) | 1.08 (0.78, 1.48) |
2D 20/20 M0,6 | 9–14 | 53 | 1319.8 (1084.1, 1606.7) | - | |
HPV-18 | 3D 20/20 M0,1,6 | 15–25 | 79 | 604.5 (475.9, 768.0) | 1.11 (0.78, 1.58) |
2D 20/20 M0,6 | 9–14 | 52 | 542.9 (426.5, 691.0) | - |
2D, 2-dose schedule; 3D, 3-dose schedule; 20/20, 20 μg each of HPV-16 and -18 L1 virus-like particles; 95% CI, exact 95% confidence interval; EU/mL, ELISA unit per milliliter; GMT, geometric mean antibody titer; M, month; N, number of evaluable seronegative subjects in the according-to-protocol immunogenicity cohort.