Antipertussis GMTs and Estimated Fold Difference at 4 Weeks Postvaccination in the Per-Protocol Population for Tdap

Concomitant (Group A),aN = 619Nonconcomitant (Group B),aN = 618Estimated Fold Difference Group A/Group B (97.5% CI)
nEstimated GMT (ELU/m)97.5% CInEstimated GMT (ELU/m)97.5% CI
 Day 15947.5(6.8 to 8.2)5647.1(6.5 to 7.8)
 4 wk postvaccination59528.5(25.8 to 31.5)56635.7(32.3 to 39.6)0.80 (0.69 to 0.92)b
 Day 159433.0(30.4 to 35.8)56432.8(30.1 to 35.7)
 4 wk postvaccination595184.1(171.8 to 197.4)566201.4(187.6 to 216.3)0.91 (0.83 to 1.01)b
 Day 159420.9(19.2 to 22.8)56420.4(18.6 to 22.4)
 4 wk postvaccination595328.4(300.6 to 358.8)566344.0(314.2 to 376.7)0.95 (0.84 to 1.08)b
 Day 159416.1(14.3 to 18.2)56415.8(13.9 to 18.1)
 4 wk postvaccination595653.0(556.0 to 767.1)566681.4(577.8 to 803.7)0.96 (0.76 to 1.21)b
  • 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 noninferiority <.001 for all antigens with the exception of anti-pertussis toxin, where P for noninferiority was .003. The noninferiority criterion for end points reported in this table was defined as statistically <1.5-fold 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 97.5% CI for the fold difference was >0.67.