Table 1.
Characteristic | All participants |
9–17 years cohort |
18–26 years cohort |
27–45 years cohort |
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---|---|---|---|---|---|---|---|---|---|---|---|---|
Placebo | Vaccine | p value | Placebo | Vaccine | p value | Placebo | Vaccine | p value | Placebo | Vaccine | p value | |
N = | 540 | 524 | 276 | 268 | 98 | 95 | 166 | 161 | ||||
Age (y), median | 17.2 | 17.4 | .631 | 13.2 | 13.2 | .743 | 24.0 | 24.0 | .521 | 37.0 | 39.0 | .044* |
Height (cm), median | 153 | 153 | .250 | 149 | 150 | .215 | 155 | 155 | .663 | 155 | 155 | .180 |
Weight (kg), median | 45.9 | 46.2 | .155 | 39.3 | 40.0 | .559 | 47.1 | 47.9 | .888 | 52.6 | 55.0 | .006* |
Ethnic group (n) | ||||||||||||
Han | 437 | 435 | .103 | 220 | 223 | .141 | 84 | 79 | .372 | 133 | 133 | .646 |
Zhuang | 45 | 32 | 26 | 16 | 7 | 4 | 12 | 12 | ||||
Yao | 58 | 53 | 30 | 26 | 7 | 12 | 21 | 15 | ||||
Other | 0 | 4 | 0 | 3 | 0 | 0 | 0 | 1 | ||||
Baseline seropositivity rates (n, %) | ||||||||||||
HPV16 | 8 (1.5) | 20 (3.8) | .017* | 1 (0.4) | 3 (1.1) | .366 | 3 (3.1) | 3 (3.2) | 1.000 | 4 (2.4) | 14 (8.7) | .013* |
HPV18 | 14 (2.6) | 20 (3.8) | .256 | 5 (1.8) | 5 (1.9) | 1.000 | 3 (3.1) | 4 (4.2) | .718 | 6 (3.6) | 11 (6.8) | .190 |
Baseline GMTs c | ||||||||||||
HPV16 | 20.5 | 21.3 | .057 | 20.1 | 20.5 | .224 | 20.7 | 21.7 | .453 | 21.1 | 22.5 | .185 |
HPV18 | 20.8 | 21.2 | .233 | 20.5 | 20.8 | .542 | 21.0 | 21.2 | .842 | 21.0 | 22.0 | .267 |
* indicates significant differences were observed between groups.
a. PPS = Per Protocol Set which includes those who received all doses of vaccine or placebo on schedule and provided paired blood samples.
b. iPPS = Immunogenicity Per Protocol Set which excludes those who were seropositive at baseline.
c. GMTs indicates geometric mean neutralization titers.