TABLE 5

AE Summary in Subjects Who Received 9vHPV Vaccine

9vHPV Vaccine
All (N = 15 776)Female Subjects (n = 12 583)Male Subjects (n = 3193)
Count%Count%Count%
With ≥1 AEsa14 29590.611 66092.7263582.5
 Injection-site eventb13 37284.811 08588.1228771.6
  Pain13 11883.210 93786.9218168.3
   Mild806851.1648051.5158849.7
   Moderate449728.5394231.355517.4
   Severe5523.55144.1381.2
   Unknown10.010.000.0
  Swelling569836.1491839.178024.4
   Mild (0 to ≤2.5 cm)391424.8334826.656617.7
   Moderate (>2.5 to ≤5.0 cm)11587.310368.21223.8
   Severe (>5.0 cm)6183.95264.2922.9
   Unknown80.180.100.0
  Erythema485930.8414532.971422.4
   Mild (0 to ≤2.5 cm)389624.7330426.359218.5
   Moderate (>2.5 to ≤5.0 cm)6984.46114.9872.7
   Severe (>5 cm)2511.62161.7351.1
   Unknown140.1140.100.0
  Pruritus6364.05944.7421.3
   Mild4873.14543.6331.0
   Moderate1380.91301.080.3
   Severe110.1100.110.0
Systemic eventc818351.9677253.8141144.2
 Vaccine-relatedd systemic event421726.7350027.871722.5
  Headache209013.2176514.032510.2
  Pyrexia9556.17345.82216.9
  Nausea5033.24513.6521.6
  Dizziness3552.33172.5381.2
  Fatigue2941.92492.0451.4
Serious eventa3562.33102.5461.4
 Vaccine-relatedd event70.060.010.0
 Death70.070.100.0
Discontinuatione because of an AEa200.1150.150.2
 Because of a vaccine-relatedd event160.1110.150.2
 Because of a serious event50.040.010.0
 Because of a serious vaccine-relatedd event20.010.010.0
  • Injection-site and systemic AEs shown are those with incidence ≥2% in any vaccination group during the study. N/n = Number of subjects as-treated who received at least 1 dose of the indicated vaccine and had at least 1 follow-up visit for an AE.

  • a At any time during the study.

  • b Days 1 to 5 after any vaccination visit.

  • c Days 1 to 15 after any vaccination visit.

  • d As determined by the reporting investigator.

  • e Study vaccination withdrawn.