TABLE 4

Anti-HPV GMTs and Estimated Fold Difference at 4 Weeks After Dose 3 in the HPV Per-Protocol Populations

AntigenConcomitant (Group A),aN = 619Nonconcomitant (Group B),aN = 618Estimated Fold Difference Group A/Group Bb (95% Confidence Interval)
nEstimated GMT (mMU/mL)nEstimated GMT (mMU/mL)
HPV65012198.75142260.70.97 (0.88 to 1.08)
HPV115021495.05141547.20.97 (0.87 to 1.07)
HPV165138882.65309027.60.98 (0.89 to 1.09)
HPV185162610.45352633.90.99 (0.88 to 1.12)
HPV315142439.45362334.31.04 (0.93 to 1.17)
HPV335201268.55371276.30.99 (0.89 to 1.11)
HPV45523947.8539863.81.10 (0.97 to 1.25)
HPV525211082.75381103.70.98 (0.88 to 1.10)
HPV585191532.85371555.10.99 (0.88 to 1.10)
  • mMU, milliMerck units; N, number of subjects randomized to the respective vaccination group who received ≥1 injection; n = number of subjects contributing to the analysis.

  • a Group A (concomitant administration) received a 0.5-mL dose of 9vHPV vaccine at day 1, month 2, and month 6 and MCV4 and Tdap on day 1; Group B (nonconcomitant administration) received 9vHPV vaccine as Group A and MCV4 and Tdap at month 1.

  • b P value for noninferiority <.001 for all 9 antigens. The noninferiority criterion for GMT end points reported in this table was defined as statistically less than a twofold decrease in Group A compared with Group B. Noninferiority of GMT in Group A relative to Group B was demonstrated if the lower limit of the 95% confidence interval for the fold difference was >0.5.