TABLE 6

Estimated Percentage Point Difference in the Per-Protocol Population for MCV4 for Percent of Subjects With Fourfold or Greater Rise in Titers for N meningitidis Serogroups 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
Serogroup A466/59079.0(75.0 to 82.6)425/56475.4(71.0 to 79.3)3.8 (–1.7 to 9.3)b
Serogroup C548/59092.9(90.1 to 95.1)538/56695.1(92.6 to 96.9)−2.1 (–5.4 to 1.1)b
Serogroup W-135563/58995.6(93.3 to 97.3)553/56697.7(95.9 to 98.9)−2.1 (–4.7 to 0.3)b
Serogroup Y540/59091.5(88.6 to 93.9)506/56689.4(86.1 to 92.1)2.1 (–1.8 to 6.1)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 above and Tdap-IPV vaccine at month 1.

  • b P value for noninferiority <.001 for all antigens. The noninferiority criterion for end points reported in this table was defined as statistically <10 percentage points decrease in Group A compared with Group B. Noninferiority of percent of subjects with fourfold or greater rise in titers for N meningitidis serogroups 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.