TABLE 2.

Results of a Phase III efficacy trial comparing 9-valent human papillomavirus (HPV) vaccine (9vHPV) with quadrivalent HPV vaccine (4vHPV), per protocol population^* in females aged 16 through 26 years^†

		9vHPV		4vHPV		Vaccine efficacy
Endpoint-related types	Endpoint	No. participants	Cases	No. participants	Cases	%	(95% CI)
HPV 31, 33, 45, 52, 58	≥CIN2, VIN2/3, VaIN2/3	6,016	1	6,017	30	96.7	(80.9–99.8)
	≥CIN2	5,948	1	5,943	27	96.3	(79.5–99.8)
	6-month persistent infection	5,939	35	5,953	810	96.0	(94.4–97.2)
HPV 6, 11, 16, 18	≥CIN2§	5,823	1	5,832	1	—	—
	Anogenital warts	5,876	5	5,893	1	—	—

Abbreviations: CI = confidence interval; ≥CIN2 = cervical intraepithelial neoplasia grade 2 or 3 or adenocarcinoma in situ; VaIN2/3 = vaginal intraepithelial neoplasia grade 2 or 3; VIN2/3 = vulvar intraepithelial neoplasia grade 2 or 3.

Sources: Package insert available at http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM426457.pdf. Joura EA, Giuliano AR, Iversen OE, et al. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med 2015;372:711–23.

^*Females who received all 3 vaccinations within 1 year of enrollment, did not have major deviations from the study protocol, were naïve (polymerase chain reaction [PCR] negative and seronegative) to the relevant HPV type(s) before dose 1, and who remained PCR negative to the relevant HPV type(s) through 1 month after dose 3 (month 7).

^†Participants were enrolled from sites in 18 countries; median duration of follow-up was 40 months.