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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
  1. 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].
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