Table 1.
Characteristics of phase III efficacy studies in young women including end of study cohort numbers
| Vaccine | FutureI Gardasil® | Future II Gardasil® | PATRICIA Cervarix® |
|---|---|---|---|
| No. study sites |
62 |
90 |
135 |
| Countries included |
16 |
13 |
14 |
| Length of trials (years) |
4 |
4 |
4 |
| Control |
225 μg Aluminium hydroxyphosphate sulphate |
225 μg Aluminium hydroxyphosphate sulphate |
Hepatitis A Vaccine (including AS04) |
| Age (years) |
16-24 |
16-26 |
15-25 |
| Primary endpoints |
Incident HPV6/11/16/18-associated genital warts, CIN1-3, VIN1-3, ValN1-3, AIS and cervical, vaginal or vulvar cancer |
Incident HPV 16/18-associated CIN2-3, AIS or cervical cancer |
Incident HPV 16/18-associated CIN2+ |
| No. in ITT/TVC-naive cohort |
4618-4689 |
5466 |
|
| No. in ITT/TVC-naive cohort control |
4680-4735 |
5452 |
|
| No. In ITT/TVC |
8562 |
8694 |
|
| No. In ITT/TVC control | 8598 | 8708 | |
Abbreviations: AIS Adenocarcinoma in situ, CIN cervical interepithelial neoplasia, VIN/VaIN Vulvar/vaginal intraepithelial neoplasia. FUTURE I/II study number of subjects varies depending on endpoint or HPV type under analysis. Adapted from [6].