Table 1 Characteristics of phase III efficacy studies in young women including end of study cohort numbers
From: Answering human papillomavirus vaccine concerns; a matter of science and time
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 | |