Table 2.
Selected local injection site and systemic clinical reactions starting within 7 days of the first vaccine by age at enrolment for participants who received 1.0 μg (dose-ranging cohort/expanded safety cohort).
| 18–39 N = 117 | 40–59 N = 69 | 60–75 N = 78 | Total N = 264 | p-value | |
|---|---|---|---|---|---|
| Pain | 0.0001 | ||||
| Normal | 79 (67.5%) | 56 (81.2%) | 71 (91.0%) | 206 (78.0%) | |
| Grade 1 | 33 (28.2%) | 13 (18.8%) | 7 (9.0%) | 53 (20.1%) | |
| Grade 2 | 5 (4.3%) | 0 (0.0%) | 0 (0.0%) | 5 (1.9%) | |
| Tenderness/discomfort | <0.0001 | ||||
| Normal | 38 (32.5%) | 36 (52.2%) | 50 (64.1%) | 124 (47.0%) | |
| Grade 1 | 73 (62.4%) | 33 (47.8%) | 28 (35.9%) | 134 (50.8%) | |
| Grade 2 | 6 (5.1%) | 0 (0.0%) | 0 (0.0%) | 6 (2.3%) | |
| Chills/shivering | 0.84 | ||||
| Normal | 114 (97.4%) | 67 (97.1%) | 77 (98.7%) | 258 (97.7%) | |
| Grade 1 | 3 (2.6%) | 1 (1.4%) | 0 (0.0%) | 4 (1.5%) | |
| Grade 2 | 0 (0.0%) | 1 (1.4%) | 1 (1.3%) | 2 (0.8%) | |
| Myalgia (flu-like general muscle aches) | 0.12 | ||||
| Normal | 103 (88.0%) | 65 (94.2%) | 74 (94.9%) | 242 (91.7%) | |
| Grade 1 | 10 (8.5%) | 4 (5.8%) | 3 (3.8%) | 17 (6.4%) | |
| Grade 2 | 4 (3.4%) | 0 (0.0%) | 1 (1.3%) | 5 (1.9%) | |
| Arthralgia | 0.44 | ||||
| Normal | 108 (92.3%) | 66 (95.7%) | 71 (91.0%) | 245 (92.8%) | |
| Grade 1 | 9 (7.7%) | 3 (4.3%) | 6 (7.7%) | 18 (6.8%) | |
| Grade 2 | 0 (0.0%) | 0 (0.0%) | 1 (1.3%) | 1 (0.4%) | |
| Fatigue | 0.0008 | ||||
| Normal | 71 (60.7%) | 54 (78.3%) | 64 (82.1%) | 189 (71.6%) | |
| Grade 1 | 34 (29.1%) | 13 (18.8%) | 12 (15.4%) | 59 (22.3%) | |
| Grade 2 | 12 (10.3%) | 2 (2.9%) | 2 (2.6%) | 16 (6.1%) | |
| Headache | 0.07 | ||||
| Normal | 78 (66.7%) | 46 (66.7%) | 61 (78.2%) | 185 (70.1%) | |
| Grade 1 | 35 (29.9%) | 18 (26.1%) | 17 (21.8%) | 70 (26.5%) | |
| Grade 2 | 4 (3.4%) | 5 (7.2%) | 0 (0.0%) | 9 (3.4%) |
Analysis of variance (ANOVA) for grade (including, “normal,” as grade 0) used to test for difference between age groups (global test across age groups).