Table 3.
HPV type | Age group (years) | No. of samples tested | No. of samples with Detectable neutralization antibodies (%) | Geometric mean neutralization titres (95% CI) | Geometric mean ratio (95% CI)a[2-dose/3-dose, 10–14 age group] | Geometric mean ratio (95% CI)b[2-dose, 15–18 age group/3-dose, 15–18 age group] | ||||
---|---|---|---|---|---|---|---|---|---|---|
HPV 16 L1 | ||||||||||
3-dose (Days 1, 60, 180) | 10–14 | 33 | 33 | (100.0) | 14,417 | (10,550–19,702) | 1.00 | |||
15–18 | 27 | 27 | (100.0) | 6262 | (4095–9577) | 0.43 | (0.36–0.52) | 1.00 | ||
2-dose (Days 1, 180) | 10–14 | 27 | 27 | (100.0) | 10,845 | (7556–15,567) | 0.75 | (0.50–1.12) | ||
15–18 | 32 | 32 | (100.0) | 9154 | (6476–12,940) | 0.63 | (0.48–0.84) | 1.46 | (1.08–1.98) | |
HPV 18 L1 | ||||||||||
3-dose (Days 1, 60, 180) | 10–14 | 33 | 33 | (100.0) | 3296 | (2109–5150) | 1.00 | |||
15–18 | 27 | 26 | (96.3) | 1003 | (690–1459) | 0.30 | (0.21–0.45) | 1.00 | ||
2-dose (Days 1, 180) | 10–14 | 27 | 27 | (100.0) | 1112 | (654–1891) | 0.34 | (0.20–0.56) | ||
15–18 | 32 | 32 | (100.0) | 632 | (387–1033) | 0.19 | (0.13–0.28) | 0.63 | (0.44–0.91) | |
HPV 6 L1 | ||||||||||
3-dose (Days 1, 60, 180) | 10–14 | 33 | 33 | (100.0) | 19,728 | (11,167–34,852) | 1.00 | |||
15–18 | 27 | 27 | (100.0) | 9113 | (5960–13,932) | 0.46 | (0.28–0.77) | 1.00 | ||
2-dose (Days 1, 180) | 10–14 | 27 | 27 | (100.0) | 13,369 | (8509–21,006) | 0.68 | (0.52–0.89) | ||
15–18 | 32 | 32 | (100.0) | 9124 | (5765–14,439) | 0.46 | (0.31–0.68) | 1.00 | (0.57–1.75) |
CI: confidence interval; HPV: human papilloma virus.
The other specified dose schedule and age stratum were non-inferior to the standard 2-dose schedule (Days 1, 180) in girls aged 10–14 years if the lower limit of the 95% CI for the geometric mean ratio was above 0.5 (2-fold difference).
The 2-dose, 15–18 age group was non-inferior to the 3-dose, 15–18 age group if the lower limit of the 95% CI for the geometric mean ratio was above 0.5 (2-fold difference).