TABLE 3

Summary of Exclusionsa From the Per-Protocol Immunogenicity Populations for 9vHPV Vaccine and MCV4 and Tdap

Concomitant (Group A),bN = 619Nonconcomitant (Group B),bN = 618
Exclusions for the 9vHPV vaccine
 Number randomized who received ≥1 injection, n619618
 Number excluded from the per-protocol immunogenicity analyses, n (%)
  HPV6/11117 (18.9)104 (16.8)
  HPV16106 (17.1)88 (14.2)
  HPV18103 (16.6)83 (13.4)
  HPV31105 (17.0)82 (13.3)
  HPV3399 (16.0)81 (13.1)
  HPV4596 (15.5)79 (12.8)
  HPV5298 (15.8)80 (12.9)
  HPV58100 (16.2)81 (13.1)
 Reasons for exclusion, n (%)
  Did not receive MCV4 or Tdap0 (0.0)18 (2.9)
  Received incorrect clinical material0 (0.0)2 (0.3)
  Received nonstudy vaccinationc6 (1.0)8 (1.3)
  Received immunosuppressives before month 70 (0.0)2 (0.3)
  Incorrectly randomized2 (0.3)0 (0.0)
  History of immune disorder1 (0.2)3 (0.5)
  Did not complete the 3-dose regimen of 9vHPV vaccine32 (5.2)29 (4.7)
  Received ≥1 dose of 9vHPV vaccine outside the acceptable day range10 (1.6)7 (1.1)
  Serum sample or results missing at day 13 (0.5)2 (0.3)
  Serum sample or results missing at month 778 (12.6)60 (9.7)
  Day 1 seropositive,d n (%)n (%)
   HPV6/11e27 (4.4)31 (5.0)
   HPV1613 (2.1)16 (2.6)
   HPV1810 (1.6)8 (1.3)
   HPV3111 (1.8)5 (0.8)
   HPV335 (0.8)4 (0.6)
   HPV452 (0.3)2 (0.3)
   HPV524 (0.6)3 (0.5)
   HPV589 (1.5)5 (0.8)
Exclusions for MCV4 and Tdap
 Number randomized who received ≥1 injection619618
 Number excluded from the per-protocol immunogenicity analyses, n (%)24 (3.9)52 (8.4)
 Reason for exclusion, n (%)
  Did not receive MCV4 or Tdap0 (0.0)18 (2.9)
  Received incorrect clinical material0 (0.0)2 (0.3)
  Received nonstudy vaccinationc3 (0.5)8 (1.3)
  Received immunosuppressives before month 70 (0.0)2 (0.3)
  Incorrectly randomized2 (0.3)0 (0.0)
  With history of immune disorder1 (0.2)3 (0.5)
  Received MCV4 and Tdap outside the acceptable day range0 (0.0)13 (2.1)
  Serum sample or results missing at 4 wk postinjection of Tdap-IPV vaccine18 (2.9)31 (5.0)
  Received incorrect Tdap dosef0 (0.0)1 (0.2)
  • a A subject may appear in >1 category.

  • b 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 with Group A together with MCV4 and Tdap at month 1.

  • c Includes (1) any live vaccine received 21 d before or 14 d after study vaccine or (2) any inactivated or recombinant vaccine received within 14 d of study vaccine.

  • d Seropositive at day 1 to the relevant HPV types(s) applies to the per protocol population for the relevant HPV type(s) only.

  • e Because the L1 proteins for HPV6 and HPV11 are 92% homologous at the amino acid level, all participants were required to be seronegative to both HPV6 and HVP11 to be included in either of the HPV6 and HPV11 per-protocol immunogenicity populations.

  • f Excluded from the per protocol immunogenicity population for Tdap; not excluded from the per protocol immunogenicity population for MCV4.