TABLE 3

AEs Reported From Day 1 to Day 15 After a Vaccination Visit in Study 001 in Female Subjects Aged 16 to 26 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, n70696997690970717076699269097078
Subjects with the following AEs, n (%)
 With ≥1 AEa5681 (80.4)5565 (79.5)5297 (76.7)6640 (93.9)5183 (73.2)4936 (70.6)4788 (69.3)6419 (90.7)
  Injection-site AEb5123 (72.5)5258 (75.1)5081 (73.5)6414 (90.7)4316 (61.0)4493 (64.3)4447 (64.4)6012 (84.9)
   Pain4999 (70.7)5143 (73.5)4946 (71.6)6356 (89.9)4119 (58.2)4351 (62.2)4322 (62.6)5910 (83.5)
    Mild4157 (58.8)3743 (53.5)3391 (49.1)3754 (53.1)3587 (50.7)3477 (49.7)3176 (46.0)4043 (57.1)
    Moderate794 (11.2)1278 (18.3)1377 (19.9)2300 (32.5)504 (7.1)803 (11.5)1031 (14.9)1682 (23.8)
    Severe48 (0.7)122 (1.7)178 (2.6)302 (4.3)28 (0.4)71 (1.0)115 (1.7)185 (2.6)
   Swelling886 (12.5)1629 (23.3)1953 (28.3)2830 (40.0)660 (9.3)1020 (14.6)1290 (18.7)2035 (28.8)
    Mild (0 to ≤2.5 cm)712 (10.1)1225 (17.5)1414 (20.5)1958 (27.7)558 (7.9)846 (12.1)1020 (14.8)1594 (22.5)
    Moderate (>2.5 to ≤5.0 cm)130 (1.8)299 (4.3)366 (5.3)597 (8.4)78 (1.1)137 (2.0)204 (3.0)332 (4.7)
    Severe (>5.0 cm)43 (0.6)104 (1.5)171 (2.5)272 (3.8)24 (0.3)37 (0.5)66 (1.0)109 (1.5)
    Unknown1 (0.0)1 (0.0)2 (0.0)3 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
   Erythema749(10.6)1261 (18.0)1564 (22.6)2407 (34.0)575 (8.1)900 (12.9)1078 (15.6)1810 (25.6)
    Mild (0 to ≤2.5 cm)665 (9.4)1074 (15.3)1278 (18.5)1921 (27.2)523 (7.4)813 (11.6)929 (13.4)1555 (22.0)
    Moderate (>2.5 to ≤5.0 cm)73(1.0)150 (2.1)211 (3.1)370 (5.2)38 (0.5)69 (1.0)119 (1.7)197 (2.8)
    Severe (>5 cm)11 (0.2)37 (0.5)73 (1.1)114 (1.6)14 (0.2)17 (0.2)29 (0.4)57 (0.8)
    Unknown0 (0.0)0 (0.0)2 (0.0)2 (0.0)0 (0.0)1 (0.0)1 (0.0)1 (0.0)
   Pruritus146 (2.1)149 (2.1)195 (2.8)388 (5.5)104 (1.5)95 (1.4)140 (2.0)282 (4.0)
    Mild121 (1.7)126 (1.8)148 (2.1)301 (4.3)89 (1.3)76 (1.1)110 (1.6)223 (3.2)
    Moderate23 (0.3)20 (0.3)44 (0.6)80 (1.1)14 (0.2)19 (0.3)28 (0.4)56 (0.8)
    Severe2 (0.0)3 (0.0)3 (0.0)7 (0.1)1 (0.0)0 (0.0)2 (0.0)3 (0.0)
 Systemic eventa2721 (38.5)1916 (27.4)1562 (22.6)3948 (55.8)2716 (38.4)1802 (25.8)1444 (20.9)3883 (54.9)
  Vaccine-relatedc systemic event1253 (17.7)823 (11.8)720 (10.4)2086 (29.5)1173 (16.6)759 (10.9)628 (9.1)1929 (27.3)
   Headache606 (8.6)382 (5.5)327 (4.7)1031 (14.6)580 (8.2)360 (5.1)298 (4.3)969 (13.7)
   Pyrexia100 (1.4)146 (2.1)150 (2.2)357 (5.0)90 (1.3)117 (1.7)122 (1.8)301 (4.3)
   Nausea196 (2.8)98 (1.4)64 (0.9)311 (4.4)149 (2.1)80 (1.1)69 (1.0)261 (3.7)
   Dizziness123 (1.7)67 (1.0)50 (0.7)211 (3.0)111 (1.6)59 (0.8)51 (0.7)197 (2.8)
   Fatigue99 (1.4)55 (0.8)45 (0.7)166 (2.3)93 (1.3)48 (0.7)39 (0.6)150 (2.1)
Serious eventa9 (0.1)7 (0.1)9 (0.1)25 (0.4)6 (0.1)7 (0.1)4 (0.1)17 (0.2)
 Vaccine-relatedc event1 (0.0)0 (0.0)1 (0.0)2 (0.0)0 (0.0)1 (0.0)0 (0.0)1 (0.0)
 Death1 (0.0)0 (0.0)0 (0.0)1 (0.0)0 (0.0)0 (0.0)1 (0.0)1 (0.0)
Discontinuationd because of an AEa5 (0.1)2 (0.0)0 (0.0)7 (0.1)0 (0.0)3 (0.0)0 (0.0)3 (0.0)
 Because of a vaccine-relatedc event3 (0.0)2 (0.0)0 (0.0)5 (0.1)0 (0.0)3 (0.0)0 (0.0)3 (0.0)
 Because of a serious event2 (0.0)0 (0.0)0 (0.0)2 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
 Because of a serious vaccine-relatedc event1 (0.0)0 (0.0)0 (0.0)1 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Subjects with temperature data, n699569136743702270036.91467257024
Subjects with the following maximum temperatures, n (%)b
 ≥37.8°C119 (1.7)177 (2.6)182 (2.7)424 (6.0)118 (1.7)169 (2.4)166 (2.5)414 (5.9)
 ≥38.9°C21 (0.3)23 (0.3)26 (0.4)68 (1.0)12 (0.2)22 (0.3)22 (0.3)53 (0.8)
  • Injection-site and systemic AEs shown are those with incidence ≥2% in any vaccination group during the study. Final analyses for AEs reported from day 1 to day 15 after a vaccination visit conducted based on a visit cutoff date of April 10, 2013.

  • 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.