Table 4.
Summary of systemic clinical adverse experiences (≥1%) among participants with detailed safety data (days 1–15 following vaccination)
| qHPV (N = 2020) | Placebo (N = 2029) | |||||||
| All adverse experiences | VR | All adverse experiences | VR | |||||
| n | (%) | n | (%) | n | (%) | n | (%) | |
| Subjects in analysis population | 2020 | 2029 | ||||||
| Subjects with follow-up | 1945 | 1950 | ||||||
| Number (%) of Subjects with one or more systemic adverse experiences | 616 | (31.7) | 613 | (31.4) | ||||
| Gastrointestinal Disorders | 125 | (6.4) | 35 | (1.8) | 120 | (6.2) | 33 | (1.7) |
| Diarrhoea | 40 | (2.1) | 10 | (0.5) | 36 | (1.8) | 13 | (0.7) |
| Nausea | 27 | (1.4) | 16 | (0.8) | 16 | (0.8) | 7 | (0.4) |
| Abdominal pain upper | 19 | (1.0) | 5 | (0.3) | 23 | (1.2) | 7 | (0.4) |
| General Disorders | 161 | (8.3) | 110 | (5.7) | 169 | (8.7) | 122 | (6.3) |
| Pyrexia | 120 | (6.2) | 93 | (4.8) | 125 | (6.4) | 98 | (5.0) |
| Fatigue | 13 | (0.7) | 6 | (0.3) | 19 | (1.0) | 15 | (0.8) |
| Infections and Infestations | 182 | (9.4) | 18 | (0.9) | 187 | (9.6) | 20 | (1.0) |
| Influenza | 42 | (2.2) | 9 | (0.5) | 44 | (2.3) | 7 | (0.4) |
| Nasopharyngitis | 44 | (2.3) | 3 | (0.2) | 50 | (2.6) | 5 | (0.3) |
| Pharyngitis | 22 | (1.1) | 1 | (0.1) | 20 | (1.0) | ||
| Upper respiratory tract infection | 27 | (1.4) | 3 | (0.2) | 20 | (1.0) | 4 | (0.2) |
| Injury, Poisoning and Procedural Complications | 30 | (1.5) | 24 | (1.2) | ||||
| Musculoskeletal and Connective Tissue Disorders | 61 | (3.1) | 21 | (1.1) | 50 | (2.6) | 15 | (0.8) |
| Nervous System Disorders | 207 | (10.6) | 121 | (6.2) | 231 | (11.8) | 137 | (7.0) |
| Headache | 179 | (9.2) | 107 | (5.5) | 207 | (10.6) | 119 | (6.1) |
| Dizziness | 19 | (1.0) | 12 | (0.6) | 18 | (0.9) | 14 | (0.7) |
| Respiratory, Thoracic And Mediastinal Disorders | 70 | (3.6) | 25 | (1.3) | 68 | (3.5) | 8 | (0.4) |
| Oropharyngeal pain | 38 | (2.0) | 14 | (0.7) | 37 | (1.9) | 2 | (0.1) |
| Skin And Subcutaneous Tissue Disorders | 26 | (1.3) | 10 | (0.5) | 31 | (1.6) | 14 | (0.7) |
VR, vaccine related. Entries in this column refer to the number (%) of subjects with systemic adverse experiences that were determined by the investigator to be possibly, probably or definitely related to the vaccine. Percentages are calculated based on the number of subjects with follow-up. Although a subject may have had two or more systemic adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories. Adverse experience terms are from MedDRA Version 12.0.