TABLE 2.
Year 8.5 anti‐HPV‐16/18 antibody seropositivity rates and GMCs in subjects aged 9‐17 years at vaccination compared with year 6 results in women aged 18‐25 years at vaccination from the pivotal efficacy study (per‐protocol set)
| Study | Seropositivity rate | GMC | |||
|---|---|---|---|---|---|
| Age group (years) | Timing a (years) | N | N | % (95% CI) | EU/mL (95% CI) |
| HPV‐16 | |||||
| Follow‐up | 223 | 223 | 100 (98.4‐100) | 1236.3 (1121.8‐1362.4) | |
| 9‐17 | 8.5 | ||||
| Pivotal efficacy | 229 | 218 | 95.2 (91.6‐97.6) | 691.7 (578.6‐826.8) | |
| 18‐25 | 6 | ||||
| HPV‐18 | |||||
| Follow‐up | 223 | 223 | 100 (98.4‐100) | 535.6 (478.6‐599.4) | |
| 9‐17 | 8.5 | ||||
| Pivotal efficacy | 229 | 220 | 96.1 (92.7‐98.2) | 355.3 (305.4‐413.4) | |
| 18‐25 | 6 | ||||
Abbreviations: CI, confidence interval; EU, ELISA unit; Follow‐up study, NCT03355820; GMC, geometric mean concentration; N, total number of subjects; n, number of seropositive subjects; Pivotal efficacy study, NCT00779766.
a
Years between first vaccine dose administration and blood sampling.