Table 3.
Percentage of solicited local and general symptoms reported during the 7-day postvaccination period overall by subject
| Symptom | Type | 3 doses gE/AS01B (N = 30) | 3 doses gE/AS01E (N = 29) | 2 doses gE/AS01B (N = 28) | 1 dose saline* (N = 30) | 3 doses saline (N = 30) |
|---|---|---|---|---|---|---|
| Local reactions, (%) 95% CI | ||||||
| Pain | Any | 90.0 (73.5-97.9) | 75.9 (56.5-89.7) | 85.7 (67.3-96.0) | 13.3 (3.8-30.7) | 23.3 (9.9-42.3) |
| Grade 3† | 10.0 (2.1-26.5) | 17.2 (5.8-35.8) | 3.6 (0.1-18.3) | 0.0 (0.0-11.6) | 0.0 (0.0-11.6) | |
| Redness | Any | 20.0 (7.7-38.6) | 24.1 (10.3-43.5) | 25.0 (10.7-44.9) | 3.3 (0.1-17.2) | 3.3 (0.1-17.2) |
| Grade 3‡ | 0.0 (0.0-11.6) | 0.0 (0.0-11.9) | 0.0 (0.0-12.3) | 0.0 (0.0-11.6) | 0.0 (0.0-11.6) | |
| Swelling | Any | 20.0 (7.7-38.6) | 13.8 (3.9-31.7) | 14.3 (4.0-32.7) | 0.0 (0.0-11.6) | 0.0 (0.0-11.6) |
| Grade 3‡ | 0.0 (0.0-11.6) | 0.0 (0.0-11.9) | 0.0 (0.0-12.3) | 0.0 (0.0-11.6) | 0.0 (0.0-11.6) | |
| General reactions, (%) 95% CI | ||||||
| Fatigue | Any | 60.0 (40.6-77.3) | 62.1 (42.3-79.3) | 71.4 (51.3-86.8) | 50.0 (31.3-68.7) | 33.3 (17.3-52.8) |
| Grade 3† | 13.3 (3.8-30.7) | 6.9 (0.8-22.8) | 3.6 (0.1-18.3) | 3.3 (0.1-17.2) | 3.3 (0.1-17.2) | |
| Grade 3 related | 10.0 (2.1-26.5) | 3.4 (0.1-17.8) | 3.6 (0.1-18.3) | 0.0 (0.0-11.6) | 0.0 (0.0-11.6) | |
| Gastrointestinal§ | Any | 33.3 (17.3-52.8) | 24.1 (10.3-43.5) | 21.4 (8.3-41.0) | 30.0 (14.7-49.4) | 13.3 (3.8-30.7) |
| Grade 3† | 0.0 (0.0-11.6) | 0.0 (0.0-11.9) | 3.6 (0.1-18.3) | 0.0 (0.0-11.6) | 0.0 (0.0-11.6) | |
| Grade 3 related | 0.0 (0.0-11.6) | 0.0 (0.0-11.9) | 0.0 (0.0-12.3) | 0.0 (0.0-11.6) | 0.0 (0.0-11.6) | |
| Headache | Any | 43.3 (25.5-62.6) | 10.3 (2.2-27.4) | 32.1 (15.9-52.4) | 23.3 (9.9-42.3) | 20.0 (7.7-38.6) |
| Grade 3† | 10.0 (2.1-26.5) | 0.0 (0.0-11.9) | 0.0 (0.0-12.3) | 0.0 (0.0-11.6) | 0.0 (0.0-11.6) | |
| Grade 3 related | 3.3 (0.1-17.2) | 0.0 (0.0-11.9) | 0.0 (0.0-12.3) | 0.0 (0.0-11.6) | 0.0 (0.0-11.6) | |
| Myalgia | Any | 70.0 (50.6-85.3) | 62.1 (42.3-79.3) | 78.6 (59.0-91.7) | 30.0 (14.7-49.4) | 26.7 (12.3-45.9) |
| Grade 3† | 26.7 (12.3-45.9) | 6.9 (0.8-22.8) | 3.6 (0.1-18.3) | 0.0 (0.0-11.6) | 3.3 (0.1-17.2) | |
| Grade 3 related | 26.7 (12.3-45.9) | 6.9 (0.8-22.8) | 3.6 (0.1-18.3) | 0.0 (0.0-11.6) | 3.3 (0.1-17.2) | |
| Fever | Any | 40.0 (22.7-59.4) | 27.6 (12.7-47.2) | 28.6 (13.2-48.7) | 23.3 (9.9-42.3) | 13.3 (3.8-30.7) |
| Grade 3‖ | 3.3 (0.1-17.2) | 0.0 (0.0-11.9) | 0.0 (0.0-12.3) | 6.7 (0.8-22.1) | 0.0 (0.0-11.6) | |
| Grade 3 related | 3.3 (0.1-17.2) | 0.0 (0.0-11.9) | 0.0 (0.0-12.3) | 3.3 (0.1-17.2) | 0.0 (0.0-11.6) | |
gE/AS01B, glycoprotein E/liposome-based adjuvant (50 µg MPL, 50 µg QS21); gE/AS01E, glycoprotein E/liposome-based adjuvant (25 µg MPL, 25 µg QS21); HCT, hematopoietic cell transplant.
*
Saline for dose 1 in the gE/AS01B 2-dose group.
†
Symptom that prevented normal activity.
‡
Diameter >100 mm.
§
Nausea, vomiting, diarrhea, or abdominal pain.
‖
Oral temperature >39.0°C.