Antigen Timing Men+Tdap+HPV Placebo+Tdap+HPV Vaccine Group Differences / Ratiosǂ     n % of subjects/GMC n % of subjects/GMC         % ≥1.0 IU/mL (95% CI)   % ≥1.0 IU/mL (95% CI) Men+Tdap+HPV minus Placebo+Tdap+HPV (95% CI) Diphtheria               Baseline 375 5 (3, 8) 380 3 (2, 5) 2 (-1, 5)   Month 1 376 95 (93, 97) 382 82 (78, 86) 13 (9, 17) Tetanus               Baseline 375 28 (24, 33) 380 28 (23, 32) 1 (-6, 7)   Month 1 376 99 (97, 100) 382 98 (97, 99) 0 (-2, 2) Pertussis antigen     GMC (IU/ml#) (95% CI)   GMC (95% CI) Ratio of Men+Tdap+HPV to Placebo+Tdap+HPV (95% CI) PT Baseline 375 4.77 (4.11, 5.53) 380 4.16 (3.59, 4.82) 1.15 (0.95, 1.39) Month 1 376 44 (40, 48) 382 44 (40, 48) 1.01 (0.89, 1.14) FHA Baseline 375 24 (21, 27) 380 21 (18, 23) 1.15 (0.98, 1.34) Month 1 376 202 (187, 218) 382 240 (222, 259) 0.84 (0.76, 0.93) Pertactin Baseline 375 20 (18, 23) 380 21 (18, 24) 0.99 (0.83, 1.18) Month 1 376 330 (300, 363) 382 403 (367, 443) 0.82 (0.72, 0.93)

Table 2: Differences in Tdap antigen-specific immune responses between the Men+Tdap+HPV and Placebo+Tdap+HPV groups. Percentages (95% confidence intervals) of subjects with seroprotective anti-diphtheria toxin and anti-tetanus toxin antibody levels and GMCs (95% confidence intervals) of antibodies against pertussis antigens, at baseline and one month after Tdap vaccination. ǂBold values indicate that the non-inferiority criteria were met. #GMCs are shown as ELISA units/ml