TABLE 7

Estimated Percentage Point Difference in the Per-Protocol Population for Tdap for Percent of Subjects With Diphtheria and Tetanus Titers ≥0.1 IU/mL at 4 Weeks Postvaccination

Concomitant (Group A),aN = 619Nonconcomitant (Group B),aN = 618Estimated Percentage Point Difference Group A – Group B (97.5% CI)
m/n%97.5% CIm/n%97.5% CI
Diphtheria titer ≥0.1 IU/mL
 Day 1403/59368.0(63.5 to 72.2)391/56469.3(64.8 to 73.6)
 4 wk postvaccination595/595100(99.3 to 100)566/566100(99.2 to 100)0.0 (–0.8 to 0.9)b
Tetanus titer ≥0.1 IU/mL
 Day 1460/57380.3(76.3 to 83.9)450/54882.1(78.1 to 85.6)
 4 wk postvaccination593/59499.8(98.9 to 100)562/562100(99.2 to 100)−0.2 (–1.2 to 0.7)b
  • m = number of subjects with the indicated response; N, number of subjects randomized to the respective vaccination group who received at least 1 injection; n, number of subjects contributing to the analysis. CI, confidence interval.

  • 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 Tdap-IPV vaccine at month 1.

  • b P value for non-inferiority <0.001 for all antigens. The non-inferiority criterion for endpoints reported in this table was defined as statistically less than 10 percentage points decrease in Group A compared with Group B. Non-inferiority of percent with titer ≥ 0.1 IU/mL in Group A relative to Group B was demonstrated if the lower limit of the 97.5% CI for the percentage point difference was greater than −10.