TABLE 1

Noninferiority Criteria Corresponding to the Primary Hypotheses Related to Immunogenicity

AntigenParamateraExpected Rates/SDsNoninferiority MarginPower
HPV type 6, 11, 16, 18, 31, 33, 45, 52, 58bGMTσ = 1.2Twofold decrease>99.9%
N meningitidis Serogroup A% with fourfold or greater rise in titer90%10 percentage points99.8%
N meningitidis Serogroup C% with fourfold or greater rise in titer90%10 percentage points99.8%
N meningitidis Serogroup Y% with fourfold or greater rise in titer80%10 percentage points95.1%
N meningitidis Serogroup W-135% with fourfold or greater rise in titer95%10 percentage points>99.9%
Diphtheria% with titer >0.1 IU/mL95%10 percentage points>99.9%
Tetanus% with titer >0.1 IU/mL92%10 percentage points99.8%
Pertussis PTGMTσ = 1.01.5-fold decrease>99.9%
Pertussis FHAGMTσ = 0.81.5-fold decrease>99.9%
Pertussis PRNGMTσ = 1.31.5-fold decrease>99.9%
Pertussis FIMGMTσ = 1.51.5-fold decrease97.0%
  • a Noninferiority of anti-HPV GMTs was measured at 4 weeks after dose 3 of 9vHPV vaccine. Noninferiority of N meningitidis serogroups A/C/Y/W-135, diphtheria, tetanus, and pertussis was measured 4 weeks postvaccination with MCV4 and Tdap.

  • b Each HPV type is tested separately