TABLE 1

Phase III Studies of the 9vHPV Vaccine Contributing to the Combined Safety Analysis

StudyKey ObjectivesSafety PopulationVaccinationDuration of Safety Follow-up
001Immunogenicity, efficacy vs qHPVWomen aged 16–26 y (N = 14 185)9vHPV: N = 7092,a qHPV: N = 7093Up to 72 mob
002Adult-to-adolescent immunobridgingGirls (n = 1933) and boys (n = 666) aged 9–15 y; women aged 16–26 y (n = 467)9vHPV: N = 3066Girls/boys: 36 mo; women: 12 mo
003Women-to-men immunobridgingMen (n = 1416) and women (n = 1099) aged 16–26 y9vHPV: N = 251512 mo
005Concomitant use: Menactra/AdacelGirls (n = 620) and boys (n = 617) aged 11–15 y9vHPV: N = 12377 mo
006Assessment in previous qHPV vaccine recipientsGirls aged 12–15 y (n = 120); women aged 16–26 y (n = 493)9vHPV: N = 613c7 mo
007Concomitant use: RepevaxGirls (n = 526) and boys (n = 526) aged 11–15 y9vHPV: N = 10527 mo
009qHPV-to-9vHPV immunobridgingGirls aged 9–15 y (N = 598)9vHPV: N = 300; qHPV: N = 2987 mo
  • Study 001 (NCT00543543; protocol V503-001)8; Study 002 (NCT00943722; protocol V503-002)9; Study 003 (NCT01651949; protocol V503-003)10; Study 005 (NCT00988884, protocol V503-005)11; Study 006 (NCT01047345; protocol V503-006)12; Study 007 (NCT01073293; protocol V503-007)13; Study 009 (NCT01304498; protocol V503-009/GDS01C).14 N/n = subjects who received at least 1 vaccination and did not receive a mixed vaccine regimen. A total of 15 875 subjects received at least 1 vaccination in these studies. Most subjects (97.2%; 15 427 of 15 875) received the 3 vaccinations.

  • a Subjects who received the low-dose or high-dose formulation of 9vHPV vaccine during the dose selection portion of the study8,15 are not considered in this report; safety findings in these subjects are reported in Luxembourg et al.16

  • b Visit cutoff date: March 10, 2014; maximum follow-up 72 mo after vaccination dose 1 (median: 48 mo).

  • c Subjects who received placebo in Study 006 are not considered in this report; safety findings in these subjects are reported.12