TABLE 4

AEs reported From Day 1 to Day 15 After a Vaccination Visit in Study 009 in Female Subjects Aged 9 to 15 Years

9vHPV VaccineqHPV Vaccine
After Dose 1After Dose 2After Dose 3After Any DoseAfter Dose 1After Dose 2After Dose 3After Any Dose
Subjects with follow-up, n300297296299299299294300
Subjects with the following AEs, n (%)
 With ≥1 AEa249 (83.0)230 (77.4)237 (80.1)287 (96.0)235 (78.6)215 (71.9)217 (73.8)281 (93.7)
  Injection-site eventb222 (74.0)222 (74.7)229 (77.4)274 (91.6)202 (67.6)202 (67.6)207 (70.4)265 (88.3)
   Pain215 (71.7)211 (71.0)220 (74.3)267 (89.3)198 (66.2)198 (66.2)204 (69.4)265 (88.3)
    Mild170 (56.7)142 (47.8)149 (50.3)142 (47.5)158 (52.8)136 (45.5)138 (46.9)158 (52.7)
    Moderate43 (14.3)63 (21.2)62 (20.9)108 (36.1)38 (12.7)58 (19.4)61 (20.7)97 (32.3)
    Severe2 (0.7)6 (2.0)9 (3.0)17 (5.7)2 (0.7)4 (1.3)5 (1.7)10 (3.3)
   Swelling42 (14.0)71 (23.9)107 (36.1)143 (47.8)31 (10.4)53 (17.7)74 (25.2)108 (36.0)
    Mild (0 to ≤2.5 cm)36 (12.0)50 (16.8)81 (27.4)100 (33.4)18 (6.0)36 (12.0)51 (17.3)68 (22.7)
    Moderate (>2.5 to ≤5.0 cm)5 (1.7)14 (4.7)15 (5.1)25 (8.4)11 (3.7)9 (3.0)11 (3.7)21 (7.0)
    Severe (>5.0 cm)1 (0.3)7 (2.4)11 (3.7)18 (6.0)2 (0.7)8 (2.7)12 (4.1)19 (6.3)
   Erythema21 (7.0)46 (15.5)63 (21.3)102 (34.1)29 (9.7)43 (14.4)54 (18.4)88 (29.3)
    Mild (0 to ≤2.5 cm)19 (6.3)39 (13.1)55 (18.6)86 (28.8)26 (8.7)40 (13.4)38 (12.9)67 (22.3)
    Moderate (>2.5 to ≤5.0 cm)2 (0.7)6 (2.0)4 (1.4)11 (3.7)3 (1.0)2 (0.7)11 (3.7)15 (5.0)
    Severe (>5 cm)0 (0.0)1 (0.3)4 (1.4)5 (1.7)0 (0.0)1 (0.3)5 (1.7)6 (2.0)
   Pruritus4 (1.3)4 (1.3)7 (2.4)12 (4.0)2 (0.7)6 (2.0)5 (1.7)8 (2.7)
   Hematoma5 (1.7)5 (1.7)2 (0.7)11 (3.7)7 (2.3)4 (1.3)5 (1.7)14 (4.7)
   Induration2 (0.7)2 (0.7)2 (0.7)6 (2.0)1 (0.3)1 (0.3)2 (0.7)3 (1.0)
   Hemorrhage2 (0.7)0 (0.0)2 (0.7)3 (1.0)2 (0.7)4 (1.3)1 (0.3)6 (2.0)
Systemic eventa102 (34.0)47 (15.8)41 (13.9)142 (47.5)107 (35.8)58 (19.4)53 (18.0)156 (52.0)
 Vaccine-relatedc systemic event41 (13.7)24 (8.1)15 (5.1)62 (20.7)44 (14.7)23 (7.7)18 (6.1)73 (24.3)
  Headache25 (8.3)15 (5.1)3 (1.0)34 (11.4)24 (8.0)10 (3.3)7 (2.4)34 (11.3)
  Pyrexia6 (2.0)5 (1.7)4 (1.4)15 (5.0)2 (0.7)5 (1.7)1 (0.3)8 (2.7)
  Nausea5 (1.7)2 (0.7)3 (1.0)9 (3.0)2 (0.7)3 (1.0)6 (2.0)11 (3.7)
  Fatigue0 (0.0)0 (0.0)0 (0.0)0 (0.0)5 (1.7)3 (1.0)1 (0.3)8 (2.7)
Serious eventa0 (0.0)1 (0.3)0 (0.0)1 (0.3)1 (0.3)1 (0.3)0 (0.0)2 (0.7)
 Vaccine-relatedc event0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
 Death0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Discontinuationd because of an AEa0 (0.0)1 (0.3)0 (0.0)1 (0.3)0 (0.0)1 (0.3)0 (0.0)1 (0.3)
 Because of a vaccine-relatedc event0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
 Because of a serious event0 (0.0)1 (0.3)0 (0.0)1 (0.3)0 (0.0)1 (0.3)0 (0.0)1 (0.3)
 Because of a serious vaccine-relatedc event0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Subjects with temperature data, n300294295299299297291300
Subjects with the following maximum temperatures, n (%)b
 ≥37.8°C7 (2.3)5 (1.7)9 (3.1)20 (6.7)5 (1.7)5 (1.7)0 (0.0)10 (3.3)
 ≥38.9°C0 (0.0)1 (0.3)3 (1.0)4 (1.3)1 (0.3)1 (0.3)0 (0.0)2 (0.7)
  • Injection-site and systemic AEs shown are those with incidence ≥2% in any vaccination group during the study. One subject randomized to 9vHPV vaccine who received 9vHPV vaccine at day 1 and qHPV vaccine at month 2 is included only in the postdose 1 analysis for 9vHPV vaccine.

  • a Days 1–15 after a vaccination visit.

  • b Days 1–5 after a vaccination visit.

  • c As determined by the reporting investigator.

  • d Study vaccination withdrawn.