Table 2: A Summary of HPV Vaccine Clinical Trials

Clinical Trial Vaccine Endpoint Outcome
GSK001/007 Cervarix™ N=1,113, AR=15-25 years, SF= 6 months, Mean FU= 48 months.
Objective: to examine HPV16/18 infection incidence, infection persistence, CIN1+ and adverse events.		 Efficacy was 91.6% against HPV16/18 infection and 100% against persistent infection with HPV16/18.
PATRICIA Cervarix™ N=18,644, AR=15-25 years, SF= 12 months, Mean FU= 15 months.
Objective: to examine HPV16/18 CIN2+, infection persistence, CIN1+ and adverse events.		 There was 100% reduction against HPV16/18 CIN2/3. Efficacy against 6 month and 12 month HPV16/18 persistent infection was 93.8% and 91.2%, respectively.
Merck 007 Gardasil® N=552, AR=16-23 years, SF= 6 months, Mean FU= 60 months.
Objective: to examine HPV6/11/16/18 infection persistence, cervical and external genital disease and adverse events.		 Persistent infection with HPV6/11/16/18 was reduced by 89%.
FUTURE I Gardasil® N=5,455, AR=16-24 years, SF= 6 months, Mean FU= 36 months.
Objective: to examine HPV6/11/16/18 CIN1+, external genital lesions and adverse events.		 HPV associated genital warts was reduced by 100%. Vaccination reduced vulvar, vaginal and perianal lesions by 34% and reduced cervical lesions by 20% regardless of HPV type.
FUTURE II Gardasil® N=12,167, AR=15-26 years, SF= 12 months, Mean FU= 36 months.
Objective: to examine HPV16/18 CIN2+ and adverse events.		 HPV associated genital warts was reduced by 98%. Estimated vaccine efficacy in cervical lesions regardless of HPV type was 17%.

Abbreviations: N= number of women, AR= age range, SF= screening frequency, Mean FU= mean follow-up, CIN=Cervical Intraepithelial Neoplasia, VIN= Vulval Intraepithelial Neoplasia, VAIN= Vaginal Intraepithelial Neoplasia.