Table 3.

Phase III efficacy studies in young women: End of study cohorts

	Future I/II - Gardasil®		PATRICIA - Cervarix®		CVT - Cervarix®
	Vaccine No.	Control No.	Vaccine No.	Control No.	Vaccine No.	Control No.
ATP/PPE	Received 3 doses within a year, Remained DNA-negative to HPV6/11/16/18 or HPV16/18 through mo. 7, seronegative to HPV6/11/16/18 at baseline; no protocol violations; could have abnormal Pap at baseline		Received 3 doses, seronegative at baseline and DNA-negative to HPV16/18 through mo. 6, normal or low grade cervical cytology at baseline, no protocol violation		Received 3 doses within defined window, HPV DNA-negative for the corresponding type through mo. 6, no biopsy/treatment through mo. 6
	7864a	7865a	7338	7305	2635–2643b	2677–2697b
ITT/TVC-naïve2	Received ≤1 dose, baseline HPV DNA negative for 14 types testedc seronegative for HPV6/11/16/18, and cytology negative		Received ≤1 dose, baseline HPV DNA negative for 14 types testedd seronegative for HPV16/18, and cytology negative		Not evaluated
	4616–4689b	4680–4735b	5466	5452	Not reported	Not reported
ITT/TVC	Received ≤1 dose, regardless of compliance, enrollment HPV DNA or serology status or evidence of anogenital neoplasia		Received ≤1 dose, regardless of compliance, enrollment cytology, HPV-DNA or HPV serology status		All randomized women regardless of compliance or enrollment HPV DNA status
	8562	8598	8694	8708	3727	3793

^aIncludes subjects in Phase IIb trial 007.

^bNumber of subjects varies depending on endpoint or HPV type under analysis.

^cHPV6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59.

^dHPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68.

ATP: According to Protocol; CVT: Costa Rica HPV vaccine trial; HPV: Human papillomavirus; ITT: Intention-to-treat; PPE: Per Protocol Efficacy; TVC: Total Vaccine Cohort. Data from references [20–23, 26].