Table 1.

Bivalent HPV vaccine efficacy against individual vaccine and non-vaccine HPV types: Comparison of 6-month persistent infection.

	Phase III (Study 008-PATRICIA).^9,10 Follow-up: 4 y TVC-N^a			Phase II (Study 007).¹¹ Follow-up: up to 6.4 y ATP-E^b			Phase II (Study 023).¹² Follow-up: up to 8 y ATP-E^b
HPV Type	Vaccine N = 5427	Control N = 5399	VE % (95% CI)	Vaccine^cN = 560	Control^cN = 553	VE % (95% CI)	Vaccine N = 223	Control N = 213	VE % (95% CI)
HPV16/18	35	521	94 (91.1, 95.6)*	0	34	100 (90, 100)*	0	17	100 (80, 100)*
HPV16	22	395	95 (91.8, 96.7)*	0	27	100 (87, 100)*	0	12	100 (69, 100)*
HPV18	13	166	92 (86.5, 96)*	0	10	100 (60, 100)*	0	8	100 (50, 100)*
HPV31	38	163	77 (67.2, 84.4)*	5	9	48 (<0, 86)	6	6	10 (<0, 76)
HPV33	53	92	43 (19.3, 60.2)*	6	5	−16 (<0, 71)	6	4	−37 (<0, 68)
HPV45	13	61	79 (61.3, 89.4)*	2	4	52 (<0, 96)	5	3	−52 (<0, 70)

*= statistical significance; ATP-E = according-to-protocol for efficacy; TVC-N = total vaccinated cohort-naive; VE = vaccine effectiveness

TVC-N: included subjects who were given at least 1 vaccine dose, were evaluable for efficacy and at baseline had normal cytology, were DNA (−) for all 14 oncogenic HPV types investigated, and were sero (−) for HPV 16 and 18; cases were counted after Day 1; in Protocol 008, the efficacy analyses for HPV 16 and/or 18 were performed in the ATP-E population.

ATP-E: included subjects who met all eligibility criteria, complied with study procedures, and had data available for the efficacy measure considered; TVC-N in Protocol 008 and ATP-E in Protocol 007/023 are equivalent since subjects in 007/023 were only enrolled if they were PCR (−) to the 14 HPV types tested, sero (−) to HPV 16 and 18, and had a normal Pap test at screening.

Number of subjects represent enrollment into the initial study, Protocol 001; of these, 393 and 383 vaccine and placebo recipients, respectively, continued in the follow-up study (Protocol 007); all subjects with follow-up were included in efficacy analyses.