Concomitant (Group A),^{a}N = 619 | Nonconcomitant (Group B),^{a}N = 618 | Estimated Percentage Point Difference Group A – Group B (97.5% CI) | |||||
---|---|---|---|---|---|---|---|

m/n | % | 97.5% CI | m/n | % | 97.5% CI | ||

Serogroup A | 466/590 | 79.0 | (75.0 to 82.6) | 425/564 | 75.4 | (71.0 to 79.3) | 3.8 (–1.7 to 9.3)^{b} |

Serogroup C | 548/590 | 92.9 | (90.1 to 95.1) | 538/566 | 95.1 | (92.6 to 96.9) | −2.1 (–5.4 to 1.1)^{b} |

Serogroup W-135 | 563/589 | 95.6 | (93.3 to 97.3) | 553/566 | 97.7 | (95.9 to 98.9) | −2.1 (–4.7 to 0.3)^{b} |

Serogroup Y | 540/590 | 91.5 | (88.6 to 93.9) | 506/566 | 89.4 | (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.