Table 2.
After dose 1 | After dose 2 | After dose 3 | ||||||||||
qHPV | Placebo | qHPV | Placebo | qHPV | Placebo | |||||||
n | (%) | n | (%) | n | (%) | n | (%) | n | (%) | n | (%) | |
Subjects in analysis population | 2020 | 2029 | 1931 | 1928 | 1855 | 1845 | ||||||
Subjects with follow-up | 1945 | 1950 | 1860 | 1854 | 1806 | 1799 | ||||||
Number (%) of subjects: | ||||||||||||
With no adverse experiences | 902 | (46.4) | 946 | (48.5) | 1071 | (57.6) | 1177 | (63.5) | 1097 | (60.7) | 1205 | (67.0) |
With one or more adverse experiences | 1043 | (53.6) | 1004 | (51.5) | 789 | (42.4) | 677 | (36.5) | 709 | (39.3) | 594 | (33.0) |
Injection-site adverse experiences | 863 | (44.4) | 813 | (41.7) | 698 | (37.5) | 558 | (30.1) | 628 | (34.8) | 500 | (27.8) |
Systemic adverse experiences | 398 | (20.5) | 423 | (21.7) | 199 | (10.7) | 213 | (11.5) | 182 | (10.1) | 162 | (9.0) |
With vaccine-related† adverse experiences | 924 | (47.5) | 877 | (45.0) | 738 | (39.7) | 611 | (33.0) | 653 | (36.2) | 538 | (29.9) |
Injection-site adverse experiences | 862 | (44.3) | 812 | (41.6) | 698 | (37.5) | 558 | (30.1) | 628 | (34.8) | 500 | (27.8) |
Systemic adverse experiences | 161 | (8.3) | 169 | (8.7) | 89 | (4.8) | 101 | (5.4) | 70 | (3.9) | 65 | (3.6) |
With serious adverse experiences | 2 | (0.1) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | 3 | (0.2) | 1 | (0.1) |
With serious vaccine-related adverse experiences | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) |
Who died | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) |
Discontinued‡ due to an adverse experience | 2 | (0.1) | 1 | (0.1) | 0 | (0.0) | 3 | (0.2) | 0 | (0.0) | 0 | (0.0) |
Discontinued due to a vaccine-related adverse | 2 | (0.1) | 1 | (0.1) | 0 | (0.0) | 2 | (0.1) | 0 | (0.0) | 0 | (0.0) |
experience | ||||||||||||
Discontinued due to a serious adverse | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) |
experience | ||||||||||||
Discontinued due to a serious vaccine-related | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) |
adverse experience |
Determined by the investigator to be possibly, probably or definitely related to the vaccine.
Discontinued = Subject discontinued from therapy. Percentages are calculated based on the number of subjects with follow-up.