Table 3. Cases of CIN 2/3 or worse due to vaccine and non-vaccine HPV types by baseline infection status in the ITT population.
|
qHPV vaccine
|
Placebo
|
||||
|---|---|---|---|---|---|
| Causal HPV type in CIN 2/3 | Baseline HPV status | Cases | Rate | Cases | Rate |
| Any type | Any | 62 | 0.9 | 51 | 0.7 |
| Vaccine type(s)a | 21 | 0.3 | 27 | 0.4 | |
| Day 1-negative for causal type | 3 | <0.1 | 8 | 0.1 | |
| Day 1-positive for causal type | 18 | 3.9 | 19 | 4.7 | |
| Non-vaccine type(s)b | 40 | 0.6 | 25 | 0.4 | |
| Day 1-negative for causal type | 13 | 0.2 | 4 | 0.1 | |
| Day 1-positive for causal type | 30 | 2.3 | 22 | 1.8 | |
| Unknown type | Any | 9 | 0.1 | 9 | 0.1 |
Abbreviations: CIN=cervical intraepithelial neoplasia; qHPV=quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine; ITT=intention to treat. The sum of the vaccine type-, non-vaccine type-, and unknown type-related cases is not equal to the any type-related cases as some subjects can have both vaccine type- and non-vaccine type-related CIN 2/3 or worse.
a
Vaccine type(s)=6, 11, 16, or 18.
b
Non-vaccine type(s)=31, 33, 35, 39, 45, 51, 52, 56, 58, or 59.