Table 1.

Phase III studies of the 9vHPV vaccine contributing to the combined immunogenicity analysis.

Study	Key objectives	Experimental arm	Control arm	Included in analysesa
001	Immunogenicity, efficacy vs. qHPV	Women age 16–26 years randomized to 9vHPV vaccine (N=6799)b	Women age 16–26 years randomized to qHPV vaccine (N=6799)b	N=6792b, c
002	Adult-to-adolescent immunobridging	Girls and boys age 9–15 years (N=2604) enrolled to receive 9vHPV vaccine	Women age 16–26 years enrolled to receive 9vHPV vaccine (N=470)	N=3066
005	Co-administration with Menactra/Adacel	Girls and boys age 11–15 years randomized to concomitant arm (N=621)	Girls and boys age 11–15 years randomized to non-concomitant arm (N=620)	N=618d
007	Co-administration with Repevax	Girls and boys age 11–15 years randomized to concomitant arm (N=526)	Girls and boys age 11–15 years randomized to non-concomitant arm (N=528)	N=528d
009	qHPV-to-9vHPV immunobridging	Girls age 9–15 years randomized to 9vHPV vaccine (N=300)	Girls age 9–15 years randomized to qHPV vaccine (N=300)	N=300c

Study 001: NCT00543543 [10].

Study 002: NCT00943722 [13].

Study 005: NCT00988884 [22].

Study 007: NCT01073293 [23].

Study 009/GDS01C: NCT01304498 [12].

^aSubjects who received at least one vaccination with 9vHPV vaccine. A total of 11,304 subjects who received at least one 9vHPV vaccination are included in these analyses. Most subjects (97.7% [11,046 of 11,304]) received the three vaccinations.

^bSubjects who received the low-dose, mid-dose or high-dose formulation of 9vHPV vaccine during the dose selection portion of the study [10], [43] are not included; immunogenicity results in these subjects are reported in [44].

^cSubjects randomized to the 9vHPV vaccine who received ≥1 dose of vaccine.

^dSubjects randomized to the non-concomitant arm who received ≥1 dose of 9vHPV vaccine. Subjects randomized to the concomitant arm of studies 005 and 007 are not considered in this report; immunogenicity results in these subjects are reported in [22], [23].