TABLE 6

Subjects With Serious AEs During the Study,a by System Organ Class, in Subjects Who Received 9vHPV Vaccine

Within 15 Days After Any Vaccination (n = 15 776)At Any Time (n = 15 778)
Count%Count%
With ≥1 serious AEs510.33562.3
Blood and lymphatic system disorders20.020.0
Cardiac disorders00.030.0
Congenital, familial and genetic disorders00.010.0
Ear and labyrinth disorders10.010.0
Gastrointestinal disorders20.0150.1
General disorders and administration site conditions20.060.0
Hepatobiliary disorders20.050.0
Immune system disorders30.040.0
 Allergy to vaccine10.010.0
 Anaphylactic reactionb10.010.0
 Hypersensitivityb10.010.0
 Sarcoidosis00.010.0
Infections and infestations150.1750.5
Injury, poisoning, and procedural complications70.0250.2
Metabolism and nutrition disorders10.010.0
Musculoskeletal and connective tissue disorders00.040.0
Neoplasms benign, malignant and unspecified (including cysts and polyps)20.0100.1
Nervous system disorders30.0210.1
Pregnancy, puerperium and perinatal conditions10.0700.4
Psychiatric disorders40.0140.1
Renal and urinary disorders00.070.0
Reproductive system and breast disorders40.0130.1
Respiratory, thoracic, and mediastinal disorders30.080.1
Skin and subcutaneous tissue disorders00.010.0
Surgical and medical procedures10.0830.5
Vascular disorders10.050.0
  • The summaries provided are subject count and percents calculated relative to the number of subjects as-treated. System organ class categories reported are those with incidence >0% during the study. A subject is counted once within a category and may be counted in >1 category. 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 adverse event.

  • a Serious AEs were predefined as any AE that resulted in death, were deemed by the investigator to be life threatening, resulted in a persistent or significant disability or incapacity, resulted in or prolonged an existing in-patient hospitalization, or was a congenital anomaly, a cancer, or “other important medical event.” Per protocol, serious AEs were reportable regardless of causality from day 1 through 180 days after the last vaccination (or for the entire study period for studies of 7-month duration); events of fetal loss were to be reported as serious AEs for any pregnancy with a last menstrual period before 180 days after the last vaccination (or at any time during the study for studies of 7-month duration); and deaths, serious vaccine-related AEs, and (in study 001) serious procedure-related AEs were to be reported for the entire duration of the study.

  • b Allergic reaction to a nonstudy medication (anaphylactic reaction due to parenteral iron given for anemia, at 5 days after dose 3; hypersensitivity due to tramadol given for back pain, at 4 days after dose 3).